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Transdermal Specialties: Pioneering Ultrasonic Drug Delivery …
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Transdermal Specialties – ONdrugDelivery
Transdermal Specialties was a technology development company that designed delivery systems for the drug and cosmetic industries. The company had developed …
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Transdermal Specialties Global Inc – Company Profile and News
Transdermal Specialties Global, Inc. operates as a pharmaceutical company. The Company serves customers in the United States.
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Transdermal Specialties Global (TSG) announces that it has …
The company has developed an Ultrasonic active patch delivery system U-STRIPTM that uses special ultrasound frequencies to expand the pores of …
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Transdermal Specialties Global, Inc. operates as a pharmaceutical company. The Company serves customers in the United States. … Most searched …
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EXECUTIVE INTERVIEW – Transdermal Specialties: A New …
Transdermal Specialties, Inc. (TSI) has been a pioneer in Active Transdermal Delivery Systems since 2009 and has developed a new ultrasonic-based delivery …
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Transdermal Specialties Global (TSG) Completes a Phase 3 …
Transdermal Specialties Global (TSG) Completes a Phase 3 Clinical Trial of the Trans-InsulinTM Transdermal Patch.
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Date Published: 9/20/2021
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In Conversation: Bruce K. Redding Jr., CEO of Transdermal …
Redding Jr., Transdermal Specialties Global (TSG) is attempting to revolutionize drug delivery. Redding, who holds over 60 patents, is the inventor of …
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TRANSDERMAL SPECIALTIES GLOBAL, INC. :: Maryland (US)
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Transdermal Specialties, Inc. – CMOCRO
Transdermal Specialties, Inc. (TSI) is a pioneer in Ultrasonic active patch delivery systems for the drug and cosmetic industries. The Company has developed …
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- Date Published: 2020. 3. 19.
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Transdermal Specialties
Transdermal Specialties was a technology development company that designed delivery systems for the drug and cosmetic industries. The company had developed an ultrasonic transdermal delivery system, the U-Strip, with a focus on diabetes care via transdermal delivery of insulin.
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Transdermal Specialties Global (TSG) announces that it has relocated to Frederick, MD
The U-Strip™ is a patented transdermal insulin delivery patch system that uses special ultrasound frequencies to expand the pores of the skin and deliver insulin into the bloodstream – No Needles. Insulin is too large to be absorbed by the skin normally. The use of ultrasound dilates the skin pores and pushes the drug into the tissue. Now entering Phase-3 clinical trials in both the United States and South Korea, the U-Strip™ Insulin system is nearing regulatory acceptance.
The new Transdermal Laboratory is working upon an Insulin Patch as the lead product, to be followed by a Parkinson’s Patch, one for Multiple Sclerosis and a Migraine Patch. The new Transdermal Laboratory in Frederick, MD is just being staffed to explore these and other drug delivery projects, through assistance provided by the State of Maryland. Over the next 18 months the Company expects to add 15 new Maryland technical jobs.
TSG located in Frederick, MD is committed to developing innovative drug delivery systems that enhance health and improve the quality of life. The company has developed an Ultrasonic active patch delivery system U-STRIPTM that uses special ultrasound frequencies to expand the pores of the skin and deliver drugs into the bloodstream…TSG’s first product is a painless Needle-Free transdermal insulin delivery patch system. Since 2016, TSG has been a pioneer in the development of ultrasonic technologies for the pharmaceutical and cosmetic industry.
For more information on Transdermal Specialties Global please call 484.716.2165.
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Transdermal Specialties Global – Explained
Transdermal Specialties Global – Explained
Bloomberg – Are you a robot?
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Transdermal Specialties – ONdrugDelivery
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Summary of article content: Articles about Transdermal Specialties – ONdrugDelivery Transdermal Specialties was a technology development company that designed delivery systems for the drug and cosmetic industries. The company had developed … …
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Transdermal Specialties Global (TSG) announces that it has relocated to Frederick, MD
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Summary of article content: Articles about Transdermal Specialties Global (TSG) announces that it has relocated to Frederick, MD The company has developed an Ultrasonic active patch delivery system U-STRIPTM that uses special ultrasound frequencies to expand the pores of … …
Most searched keywords: Whether you are looking for Transdermal Specialties Global (TSG) announces that it has relocated to Frederick, MD The company has developed an Ultrasonic active patch delivery system U-STRIPTM that uses special ultrasound frequencies to expand the pores of … Frederick, Maryland (PRWEB) October 06, 2020 — The U-Strip™ is a patented transdermal insulin delivery patch system that uses special ultrasound frequenciesPRESS RELEASE
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Transdermal Specialties Global (TSG) announces that it has relocated to Frederick, MD
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EXECUTIVE INTERVIEW – Transdermal Specialties: A New Dimension in Transdermal Drug Delivery
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Summary of article content: Articles about EXECUTIVE INTERVIEW – Transdermal Specialties: A New Dimension in Transdermal Drug Delivery Transdermal Specialties, Inc. (TSI) has been a pioneer in Active Transdermal Delivery Systems since 2009 and has developed a new ultrasonic-based delivery … …
Most searched keywords: Whether you are looking for EXECUTIVE INTERVIEW – Transdermal Specialties: A New Dimension in Transdermal Drug Delivery Transdermal Specialties, Inc. (TSI) has been a pioneer in Active Transdermal Delivery Systems since 2009 and has developed a new ultrasonic-based delivery … Bruce K. Redding, Jr, CEO and Founder of TSI, discusses the importance of developing a new tool for enhanced drug delivery, but also a means to reduce the time-to-market for new formulations while also expanding the number of drugs that can be delivered transdermally.
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EXECUTIVE INTERVIEW – Transdermal Specialties: A New Dimension in Transdermal Drug Delivery
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In Conversation: Bruce K. Redding Jr., CEO of Transdermal Specialties Global · BioBuzz
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Summary of article content: Articles about In Conversation: Bruce K. Redding Jr., CEO of Transdermal Specialties Global · BioBuzz Redding Jr., Transdermal Specialties Global (TSG) is attempting to revolutionize drug delivery. Redding, who holds over 60 patents, is the inventor of … …
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What is TSG’s origin story
We understand the U-Strip insulin patch just achieved a very important milestone Where does the insulin patch currently sit within the FDA approval process and what’s next
If approved by the FDA how will TSG’s U-Strip insulin patch positively impact the lives of those suffering from all forms of diabetes
What is the state of fundraising and scale up for the insulin patch
What is the market for transdermal drug delivery and how might it transform drug development and product commercialization in the future
What is your longer term vision for TSG and the U-Strip technology
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In Conversation: Bruce K. Redding Jr., CEO of Transdermal Specialties Global · BioBuzz
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Transdermal Specialties, Inc. – CMOCRO
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Summary of article content: Articles about Transdermal Specialties, Inc. – CMOCRO Transdermal Specialties, Inc. (TSI) is a pioneer in Ultrasonic active patch delivery systems for the drug and cosmetic industries. The Company has developed … …
Most searched keywords: Whether you are looking for Transdermal Specialties, Inc. – CMOCRO Transdermal Specialties, Inc. (TSI) is a pioneer in Ultrasonic active patch delivery systems for the drug and cosmetic industries. The Company has developed … Transdermal Specialties, Inc. (TSI) is a pioneer in Ultrasonic active patch delivery systems for the drug and cosmetic industries. The Company has developed a patented delivery system that breaks new ground in active patch technology. Transdermal Specialties, Inc., CMOCRO, PharmaCircle, Company, Company Detail, https://u-strip.com/, 400 Sagner Ave #300, Frederick, MD 21701Transdermal Specialties, Inc., CMOCRO, PharmaCircle, Company, Company Detail, https://u-strip.com/, 400 Sagner Ave #300, Frederick, MD 21701
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Transdermal Specialties Global (TSG) Completes a Phase 3 Clinical Trial of the Trans-Insulin⢠Transdermal Patch – EIN Presswire
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Summary of article content: Articles about Transdermal Specialties Global (TSG) Completes a Phase 3 Clinical Trial of the Trans-Insulin⢠Transdermal Patch – EIN Presswire Transdermal Specialties Global (TSG) Completes a Phase 3 Clinical Trial of the Trans-Insulin™ Transdermal Patch. News Proved By. …
Most searched keywords: Whether you are looking for Transdermal Specialties Global (TSG) Completes a Phase 3 Clinical Trial of the Trans-Insulin⢠Transdermal Patch – EIN Presswire Transdermal Specialties Global (TSG) Completes a Phase 3 Clinical Trial of the Trans-Insulin™ Transdermal Patch. News Proved By. TSG’s U-Strip⢠Has Successfully Achieved in Type-2 Diabetics the FDA Standard of 70% of the time, maintaining the Glucose Range Between 70 and 180 mg/dl,Trans-Insulinâ¢,The U-Stripâ¢,transdermal insulin delivery patch system
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Transdermal Specialties Global (TSG) Completes a Phase 3 Clinical Trial of the Trans-Insulin⢠Transdermal Patch – EIN Presswire
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TRANSDERMAL SPECIALTIES GLOBAL, INC. :: Maryland (US) :: OpenCorporates
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Transdermal Specialties Global, Inc. – Broomall, PA – Pharmaceuticals
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Transdermal Specialties Global (TSG) announces that it has relocated to Frederick, MD
The U-Strip™ is a patented transdermal insulin delivery patch system that uses special ultrasound frequencies to expand the pores of the skin and deliver insulin into the bloodstream – No Needles. Insulin is too large to be absorbed by the skin normally. The use of ultrasound dilates the skin pores and pushes the drug into the tissue. Now entering Phase-3 clinical trials in both the United States and South Korea, the U-Strip™ Insulin system is nearing regulatory acceptance. The new Transdermal Laboratory is working upon an Insulin Patch as the lead product, to be followed by a Parkinson’s Patch, one for Multiple Sclerosis and a Migraine Patch. The new Transdermal Laboratory in Frederick, MD is just being staffed to explore these and other drug delivery projects, through assistance provided by the State of Maryland. Over the next 18 months the Company expects to add 15 new Maryland technical jobs. TSG located in Frederick, MD is committed to developing innovative drug delivery systems that enhance health and improve the quality of life. The company has developed an Ultrasonic active patch delivery system U-STRIPTM that uses special ultrasound frequencies to expand the pores of the skin and deliver drugs into the bloodstream…TSG’s first product is a painless Needle-Free transdermal insulin delivery patch system. Since 2016, TSG has been a pioneer in the development of ultrasonic technologies for the pharmaceutical and cosmetic industry. For more information on Transdermal Specialties Global please call 484.716.2165.
EXECUTIVE INTERVIEW – Transdermal Specialties: A New Dimension in Transdermal Drug Delivery
Of the multitude of drugs that can be delivered transdermally, only about 25 compounds have found market. All are low molecular weight drugs usually lower than 500 Daltons. Larger compounds have generally been unable to be employed in transdermal delivery in which GI-By-Pass is the primary goal. As a result, it takes more research, longer clinical times, and food interaction studies to get a compound from concept to the medicine cabinet. In the United States, the average is 12 years, that is, if it makes it at all. Only 5 in 5,000 drugs that enter preclinical testing progress to human testing; 5 of these drugs that are tested in people are approved. The chance for a new drug to actually make it to market is thus only 1 in 5,000. Not very good odds. Transdermal Delivery can reduce that timeline and investment to as little as 3 years through a transdermal routing as opposed to a GI route. Therefore, there is a need for expanding the number of compounds that can be delivered transdermally. Transdermal Specialties, Inc. (TSI) has been a pioneer in Active Transdermal Delivery Systems since 2009 and has developed a new ultrasonic-based delivery system that has the promise to significantly increase the number of compounds that can be delivered transdermally, from 1 to 125,000 Daltons in molecular weight. The U-StripTM is currently being employed to provide transdermal insulin, but there are over 175 target compounds on the list. Structurally, because Transdermal Insulin is now entering Phase III trials, the company has created a subsidiary, Transdermal Global, whose sole focus is diabetes care applications. The parent company, TSI, is currently developing central nervous system applications for the U-Strip Delivery technologies, one of which will enter Phase II clinical trials in 2016. Drug Development & Delivery recently spoke with Bruce K. Redding, Jr, CEO and Founder of TSI, about the importance of developing this new tool for enhanced drug delivery, but also a means to reduce the time-to-market for new formulations while also expanding the number of drugs that can be delivered transdermally. Q: Can you provide our readers some background on Transdermal Specialties? A: TSI is developing a new form of Active Transdermal Patch system for the delivery of both small and large molecule drug delivery. In particular, our lead product is a Transdermal Insulin Patch for the treatment of diabetes. No Needles. Having completed Phase I and II clinical stages, the company is preparing for a 1,100 patient trial to complete the Phase III program with 500 subjects in the United States and 600 subjects globally. The US component of the Phase III program will involve 5 Super Clinics, each treating over 10,000 type 2 diabetics. Located in Broomall, PA, just outside of Philadelphia, TSI employs 22 researchers and technicians, and expects to add another 30 to its roles for the international program. Production capacity for the Trans-InsulinTM patch is now over 1 million patches per week and conducted at our plant in Charlotte, NC. The company plans to introduce this technology at the American Diabetes Association’s annual Scientific Sessions, June 10-14, 2016, in New Orleans. See us at booth No. 116, where we will demonstrate the effectiveness of the UStrip patch system upon type 2 volunteers in real time. In addition, the company is involved in a number of strategic relationships to adopt our delivery technology to the delivery of both small and large drugs through strategic research arrangements. This program is called the drug screening program and has already resulted in 3 successful non-insulin drugs now being planned for human clinicals in 2016. Q: How does TSI’s technology function, and why is it unique? A: Cutting Edge Technology – The U-Strip is an active transdermal delivery system using a patented alternating ultrasonic waveform process to temporarily dilate the skin pores, expanding the pore size from 50 to 110 microns in just a few seconds. This process enables large molecule drugs to permeate through the skin (stratum corneum) into the dermis and then into the blood stream. The ultrasound signal does not generate cavitation or heat like conventional ultrasound and is composed of two waveforms: Ultrasound Sawtooth Waveforms enlarge the pore size, while Square Waveforms push the drug through the expanded pores into the dermis. Designed originally for insulin delivery, there are more than 175 additional compounds that cannot normally be delivered through the skin, but are candidates for the U-Strip system. This method of drug delivery is unique and does not rely upon skin permeation, which is restricted to drugs below 1,000 Daltons. With the U-Strip system, we have delivered compounds as large as 75,000 Daltons transdermally. Market Target – The target market is type 2 diabetics, which account for 95% of all diabetes sufferers. Globally, this translates to 209 million type 2 diabetics versus 11 million type 1 diabetics. This is an underdeveloped market with most type 2 on a regimen of oral medicines. Many endocrinologists believe that type 2 would be better off through a regular dosing of insulin instead of relying on Metformin, Glucophage, and other medications because they are inconsistent in maintaining healthy glucose levels and could have long-term serious side effects. Q: Can you please discuss your development status to date? A: The kick-off product is the Trans-Insulin system, which completed a 24-hour; 12-subject clinical trial of its miniaturization program. The U-Strip System involves 4 main components: Insulin Patch, which uses an absorbent pad construction, the first on-off transdermal patch. The patch snaps onto the transducer coupler and can contain as much as 150 units of insulin, enough for a 2-day supply for most diabetics, and is disposable. Transducer Coupler, which snaps onto the Patch. The Ultrasonic Applicator consists of a transducer device that generates ultrasonic transmissions to dilate the pores, enabling large molecule drugs, such as insulin, to enter the blood stream and a keypad to operate and control the dosage level and frequency. The system is worn by the patient and is completely portable. Battery – A 9-volt battery provides portable power for multiple-day treatment regimens. The U-Strip system may be worn on the arm, over the abdomen, or on any part of the body. A control device is placed over the insulin patch. This device regulates the dosing schedule for basal and bolus insertions of insulin to maintain the glucose levels of the diabetic patient at a healthy level. The insulin patch is designed to hold a 2-day supply of insulin. Key advantages of the U-Strip/Insulin system include: – Very rapid glucose reduction. Volunteers average between 10 and 30 mg/dl reduction in just the first 5 minutes – Steady glucose reduction to healthy normal range, 95-115 mg/dl followed by glucose stabilization – Defeats glucose spikes post meal – Diagnostic & Self Correction – Dose reporting to physician via the Internet – Dose tracking memory – Improved compliance – Improved disease treatment and management – Totally non-invasive: needle-free, no catheters Q: What is the next critical milestone for TSI? A: The Phase III trial for the insulin system is about to start in 4 nations. Once that data is in, the next critical milestone will be regulatory submission and commercialization for the insulin system. Initially, the target market is type 2 diabetics, to be followed by type 1, and then an insulin patch for children. Along the way through our drug screening program, we will be testing other pharmaceutical compounds for ultrasonic transdermal delivery. Through cooperative research and strategic alliance relationships, we will actively work to expand the number of drugs that can be delivered transdermally, from less than 30 today, to 175 investigations within the next 3 years. Already we are working our way through CNS indications and soon will be investigating arthritis and cardiac care applications. Q: Will you offer co-development programs with interested potential partners? A: Yes, we are active in both internal areas beyond insulin, and we do have co-development partnering opportunities for future drug programs. Our drug screening program is expected to generate other opportunities for expanded transdermal applications. First, we treat the target compound for 8 hours using our alternating ultrasound transmission. If no damage, we move to patch development and liberation tests, followed by cadaver skin permeation studies. The whole drug screening investigation can take as little as 3 months. If the compound fails along the way, the partner has invested only in laboratory screening services. If we pass the drug screening program, human clinicals are next, and partners are offered strategic alliance options. As each opportunity manifests itself, we may create separate focus divisions or affiliations to bring those products to market. Right now, insulin has spun to a dedicated subsidiary under Transdermal Global. The CNS, arthritis, cardiac, and oncology products may each be similarly situated depending upon the needs of potential partnerships. Q: What are the future plans for the enterprise? A: Insulin is number one on the runway. As previously mentioned, we have created a subsidiary, Transdermal Global, to focus only upon diabetic care products, starting with the type 2 glucose control system, the U-Strip controller, and the low profile Trans-InsulinTM Patch. That subsidiary will be manned by professionals with diabetes care as their sole focus. Essentially, we are placing all of our diabetes researchers, marketing, and clinical teams under one focus – diabetes care. I am a full believer that emergent companies need to have a focus and thus we have placed our diabetes care unit under one roof. Transdermal Global is forming now and expects to enter Phase III clinical trials later this year. A major goal for this year beyond the Phase III trials is to expand our current pilot patch production facility to 1 million patches per week. Meanwhile, the parent company TSI, will continue its product development activities to explore the use of this patented technology to both speed the regulatory review process by avoiding the GI tract, and to expand the number of compounds that can be delivered transdermally. Our R&D teams are working upon several CNS applications, some internally sponsored, and some already with strategic partners. We are now entertaining potential research and strategic partners who may wish to have their compound tested for enhanced transdermal delivery via the U-Strip technology. For inquiries, contact Bruce K. Redding, Jr at (484) 479-3240 or [email protected]. To view this issue and all back issues online, please visit www.drug-dev.com.
In Conversation: Bruce K. Redding Jr., CEO of Transdermal Specialties Global · BioBuzz
In Conversation: Bruce K. Redding Jr., CEO of Transdermal Specialties Global Founded by former NASA mission specialist Bruce K. Redding Jr., Transdermal Specialties Global (TSG) is attempting to revolutionize drug delivery. Redding, who holds over 60 patents, is the inventor of microencapsulation technology, which his company is leveraging to develop an insulin patch as a non-invasive, needleless method for diabetes treatment. TSG recently demonstrated to the Food and Drug Administration (FDA) that its insulin patch, called the U-Strip™, was able to keep patients’ glucose levels in a safe range over multiple days. The U-Strip will now move into a six-subject trial conducted in the company’s Frederick, Maryland test clinic and, should all go well, move on to Phase III trials once the pandemic subsides in the U.S. The company plans to conduct Phase III trials in South Korea in the near future. TSG also has a patch for Parkinson’s disease that is currently in Phase I trials. Should TSG’s U-Strip insulin patch be approved by the FDA, it could revolutionize diabetes treatment across the globe by eliminating needles and rendering insulin pumps obsolete, all while delivering superior, less expensive treatment and better quality of life to patients. Redding believes that TSG’s U-Strip insulin patch is just the tip of the iceberg when it comes to TSG’s technology platform’s potential, which could revolutionize drug delivery. With TSG’s insulin patch nearing Phase III clinical trials, we thought it was a great time to catch up with Redding, who recently relocated TSG to Frederick, Maryland, from Philadelphia, bolstering Frederick’s growing reputation as a key life science sub-cluster in the BioHealth Capital Region’s (BHCR). What is TSG’s origin story? TSG’s story starts about 30 years ago, believe it or not. I was working with NASA to develop microencapsulated adhesive tiles for the bottom of the space shuttle. I left the space program and started working on microencapsulation, which I later licensed to DuPont, ConAgra, Nabisco, and a number of other companies. We made the microcapsules using ultrasound. Every year at Transdermal we have a contest to figure out what else we can use our technology for. The winning team gets a week-long trip to the Bahamas. I came up with the idea of using our technology for drug delivery. Naturally, I didn’t win the trip to the Bahamas because I’m the founder. This was a crazy idea at the time, but we took it to Penn State University and tested it in animal models and that worked. Then we asked what drugs could we deliver? The theory was that our ultrasound could open your skin pores. All drugs have a molecular size to them. Small molecule drugs are between 0 and 500 molecular weight and your body can absorb them. Between 500 and 1,000 molecular weight you need to do something special that usually involves ‘sandpapering’ the skin in some way. Anything over 1,000 molecular weight you couldn’t put through the skin. 98% of the drugs out there are too large to be transdermally admitted and there are only about 20 patches on the market today that all deliver small molecule drugs. We realized our technology delivered an unusual effect. I developed a sawtooth wave-combination square wave ultrasound. When the sawtooth wave hits your skin it enlarges your pores, then the square wave inserts the drug through the open pores. We started making microcapsules, which were first used in products like Hamburger Helper and Fruit Roll Ups for flavoring. Insulin is 6,000 molecular weight and with this ultrasound approach, we can treat people with diabetes transdermally. And there are about 175 other drugs we can possibly target as well. This is how TSG came to be and how the technology I invented has evolved over time into our U-Strip patch platform. We understand the U-Strip insulin patch just achieved a very important milestone. Where does the insulin patch currently sit within the FDA approval process and what’s next? The FDA changed its requirement for Phase III for our product. Originally the end target was A1C. Now, with the advent of continuous glucose meters, you can measure glucose levels every five minutes over a number of days. The FDA reduced the length of the Phase III study from 90 days to 14 days because of this. What we had to prove was that 70% of the time our patch kept a diabetic’s glucose range between 70-180 milligrams per deciliter for 14 days. We conducted a rehearsal study with two participants over six days. Now, we are getting ready to conduct a six volunteer study over 14 days. In our rehearsal study, we beat the FDA standard of 70% of the time-in-range requirement. One patient was 98% and the other was 88% of time-in-range. If you’re a non-diabetic your glucose is between 75-110 and we kept our patients there 80% of the time. We also looked at mealtime spikes. Diabetics take an injection about 20 minutes ahead of a meal, and many diabetics forget to do this. We found that you could press a button on our device while you’re having a meal and our device delivers 4 units of insulin in 15 minutes and this counteracts any glucose spike during a meal. We also found that the Somygi effect did not occur with our patch during the rehearsal trial. The Somgyi effect is a glucose spike that can impact your eyesight when glucose levels drop overnight. Insulin pumps and injections all have that Somygi effect at 3 or 4 in the morning, and our patch did not. Our patch avoided typical morning glucose spikes as well. We created our own clinic in Frederick because we couldn’t find any bed space for the volunteers. We needed to create a bubble for our volunteers because of COVID-19. We set this up in December 2020, ran our two volunteer rehearsal, and now we are getting ready for the 14-day FDA trial, which we expect will more than meet the FDA’s standard. After the 14-day trial, we will apply to enter our Phase III trial that is targeted to include 280 subjects in the U.S. across several clinics, including Johns Hopkins University. Once we conduct this 280 subject trial, and if we succeed, we can apply for FDA approval. In theory, we could get FDA approval next year. However, because of COVID-19 levels in the U.S., it is very difficult to recruit subjects. We’ve pivoted to conduct our trials in South Korea where COVID levels are low and fewer subjects are required. The plan is to get the insulin patch approved in South Korea over five or six months and then bring this data back to the U.S. And hopefully, COVID levels will be much lower than what they are now and we can pursue a U.S. Phase III trial. If approved by the FDA, how will TSG’s U-Strip insulin patch positively impact the lives of those suffering from all forms of diabetes? We used to believe the most important advantage of our product was eliminating needles. In some cases, diabetics have to inject themselves up to five times a day. This is a compliance problem. But now we realize there are quite a few therapeutic benefits, including the potential elimination of eye issues and neuropathy. Our data looks very promising. A lot of Type-2 diabetics become Type-1s over time because of the strain put on their pancreas because of oral medications. Our patch could remove this problem as well. Also, our U-Strip patch actually gives you insulin; it is not something that fools your body into releasing the insulin you do have. So it might actually prove to be better therapeutically than a needle or an insulin pump. Our U-Strip patch system is going to make it easier for a diabetic patient to be compliant—all they need to enter their weight, glucose levels, and press a button. It is just really easy to use. In general, we feel our patch has fewer side effects and will be far less expensive for patients than anything that’s currently on the market. From a cost perspective, our U-Strip insulin patch will provide a more economical option for diabetic patients. We break it down into daily use costs. If you use a needle, you’ll pay $4 to $6 a day; if you use a dial-up needle, the cost is about $16 a day; for an insulin pump, which costs about $7,500 to purchase, translates to about $30 a day. Our patch daily cost is about $4.50 a day so we are very competitive price-wise. What is the state of fundraising and scale up for the insulin patch? Our budget is about $250K to get the product to Phase III. We are currently seeking funding. We previously received funding from MMG out of Baltimore, which helped us move to Frederick, Maryland. One of our board members was from Akonni Biosystems in Frederick, and they provided us with some lab space. We were founded in Philadelphia, but when we needed a Class 100 clean room, Akonni helped us out. We then created our own clinic in Frederick so we now have two facilities in Frederick. Production of the patch is done in the U.S. and we have the capability today to produce 1M patches per month. This is not just a research exercise or lab product. We are in the pilot stage right now. We’re actively reaching out to raise the 250K. Then we will be off to South Korea where we have two shareholders that could help fund the rest of the trials there. There are 9M diabetics in South Korea; the facility that we’ve chosen, Severance Hospital, is also part of the Beijing Diabetes Hospital that has 1.4M diabetics in one clinic. So if we get South Korean approval, we are on the market and saving lives right away. We are thinking about going public in the future and perhaps expanding our manufacturing capabilities in Frederick, but we need to get these clinical trials done first. What is the market for transdermal drug delivery and how might it transform drug development and product commercialization in the future? We’re actively reaching out to Big Pharma companies to see what drugs they might want to test with our technology. For Big Pharma, transdermal delivery systems that bypass the gastrointestinal tract via a patch could reduce the approval process to four to five years, as opposed to 10-12 years and billions of dollars spent. On the aft end, when it comes to patent expirations and generic competition, you could possibly get a 20 year patent extension by switching delivery to a transdermal patch. We’re getting ready now to partner with Big Pharma to explore some of these ideas. We have 175 other drugs on our target list, some of which make sense and some don’t. Our patch has the most potential for chronic conditions like diabetes, Parkinson’s disease, or MS, and even severe migraines. We are currently conducting a 10 subject Phase I trial for Parkinson’s; our patch for Parkinson’s could potentially knock down tremors that are oncoming and then prevent them from coming back. In the U.S. alone there are 27M Type-2 diabetics and about 4M Type-1 diabetics. We can make 1M patches per month but that won’t even serve 1% of the diabetic population in the U.S. We plan to sell our insulin patches to Superclinics within Harvard University’s health system that has 300,000 patients, Yale’s clinic with 45,000 patients, the University of Pennsylvania’s clinic with 40,000 patients, and Johns Hopkins’ clinic with about 25,000 diabetic patients. We will aim to convert their needle patients to our patch. Diabetes in the U.S. is a huge market in and of itself. We are a small company right now—we have about 13 staff members but expect to ramp up hiring once our insulin patch is approved. We are a privately-owned and funded company with no bank debt and no grants. Up until now, we’ve done everything internally and through royalties. We need to get our insulin patch done first. And if we can get our insulin patch approved, we’ll be letting the world know that there is a new platform and new tool in the tool box for treating disease. What is your longer term vision for TSG and the U-Strip technology? I get asked that a lot, ‘What do you want to be when you grow up?’ We’re proving ourselves with our initial trials. Traditionally, we’ve secured strategic alliances with big companies and lived off the royalties. Right now there are just too many possible applications for one small biotech. We’re going to either have to develop joint ventures with the Big Boys and let them run with it. Or we could go public at some point in the future. We’ve been a patent factory for the first few years; we just secured patent number 62, but now it’s time to get our products out into the market. Right now we are building value by getting through this FDA review. You have to understand that no one has ever done transdermal insulin with the FDA before so we are cutting new ground. We know we’re going to have partners and affiliates moving forward. Our technology is new and unique—we’re the only company that can deliver drugs over 1,000 in molecular weight through the skin. Our goal is to open up the transdermal market from 20 drugs to approximately 200 at some point in the future.
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EXECUTIVE INTERVIEW – Transdermal Specialties: A New Dimension in Transdermal Drug Delivery
Of the multitude of drugs that can be delivered transdermally, only about 25 compounds have found market. All are low molecular weight drugs usually lower than 500 Daltons. Larger compounds have generally been unable to be employed in transdermal delivery in which GI-By-Pass is the primary goal. As a result, it takes more research, longer clinical times, and food interaction studies to get a compound from concept to the medicine cabinet. In the United States, the average is 12 years, that is, if it makes it at all. Only 5 in 5,000 drugs that enter preclinical testing progress to human testing; 5 of these drugs that are tested in people are approved. The chance for a new drug to actually make it to market is thus only 1 in 5,000. Not very good odds. Transdermal Delivery can reduce that timeline and investment to as little as 3 years through a transdermal routing as opposed to a GI route. Therefore, there is a need for expanding the number of compounds that can be delivered transdermally. Transdermal Specialties, Inc. (TSI) has been a pioneer in Active Transdermal Delivery Systems since 2009 and has developed a new ultrasonic-based delivery system that has the promise to significantly increase the number of compounds that can be delivered transdermally, from 1 to 125,000 Daltons in molecular weight. The U-StripTM is currently being employed to provide transdermal insulin, but there are over 175 target compounds on the list. Structurally, because Transdermal Insulin is now entering Phase III trials, the company has created a subsidiary, Transdermal Global, whose sole focus is diabetes care applications. The parent company, TSI, is currently developing central nervous system applications for the U-Strip Delivery technologies, one of which will enter Phase II clinical trials in 2016. Drug Development & Delivery recently spoke with Bruce K. Redding, Jr, CEO and Founder of TSI, about the importance of developing this new tool for enhanced drug delivery, but also a means to reduce the time-to-market for new formulations while also expanding the number of drugs that can be delivered transdermally.
Q: Can you provide our readers some background on Transdermal Specialties?
A: TSI is developing a new form of Active Transdermal Patch system for the delivery of both small and large molecule drug delivery. In particular, our lead product is a Transdermal Insulin Patch for the treatment of diabetes. No Needles. Having completed Phase I and II clinical stages, the company is preparing for a 1,100 patient trial to complete the Phase III program with 500 subjects in the United States and 600 subjects globally. The US component of the Phase III program will involve 5 Super Clinics, each treating over 10,000 type 2 diabetics. Located in Broomall, PA, just outside of Philadelphia, TSI employs 22 researchers and technicians, and expects to add another 30 to its roles for the international program. Production capacity for the Trans-InsulinTM patch is now over 1 million patches per week and conducted at our plant in Charlotte, NC. The company plans to introduce this technology at the American Diabetes Association’s annual Scientific Sessions, June 10-14, 2016, in New Orleans. See us at booth No. 116, where we will demonstrate the effectiveness of the UStrip patch system upon type 2 volunteers in real time. In addition, the company is involved in a number of strategic relationships to adopt our delivery technology to the delivery of both small and large drugs through strategic research arrangements. This program is called the drug screening program and has already resulted in 3 successful non-insulin drugs now being planned for human clinicals in 2016.
Q: How does TSI’s technology function, and why is it unique?
A: Cutting Edge Technology – The U-Strip is an active transdermal delivery system using a patented alternating ultrasonic waveform process to temporarily dilate the skin pores, expanding the pore size from 50 to 110 microns in just a few seconds. This process enables large molecule drugs to permeate through the skin (stratum corneum) into the dermis and then into the blood stream. The ultrasound signal does not generate cavitation or heat like conventional ultrasound and is composed of two waveforms: Ultrasound Sawtooth Waveforms enlarge the pore size, while Square Waveforms push the drug through the expanded pores into the dermis. Designed originally for insulin delivery, there are more than 175 additional compounds that cannot normally be delivered through the skin, but are candidates for the U-Strip system. This method of drug delivery is unique and does not rely upon skin permeation, which is restricted to drugs below 1,000 Daltons. With the U-Strip system, we have delivered compounds as large as 75,000 Daltons transdermally.
Market Target – The target market is type 2 diabetics, which account for 95% of all diabetes sufferers. Globally, this translates to 209 million type 2 diabetics versus 11 million type 1 diabetics. This is an underdeveloped market with most type 2 on a regimen of oral medicines. Many endocrinologists believe that type 2 would be better off through a regular dosing of insulin instead of relying on Metformin, Glucophage, and other medications because they are inconsistent in maintaining healthy glucose levels and could have long-term serious side effects.
Q: Can you please discuss your development status to date?
A: The kick-off product is the Trans-Insulin system, which completed a 24-hour; 12-subject clinical trial of its miniaturization program.
The U-Strip System involves 4 main components: Insulin Patch, which uses an absorbent pad construction, the first on-off transdermal patch. The patch snaps onto the transducer coupler and can contain as much as 150 units of insulin, enough for a 2-day supply for most diabetics, and is disposable.
Transducer Coupler, which snaps onto the Patch.
The Ultrasonic Applicator consists of a transducer device that generates ultrasonic transmissions to dilate the pores, enabling large molecule drugs, such as insulin, to enter the blood stream and a keypad to operate and control the dosage level and frequency. The system is worn by the patient and is completely portable.
Battery – A 9-volt battery provides portable power for multiple-day treatment regimens.
The U-Strip system may be worn on the arm, over the abdomen, or on any part of the body. A control device is placed over the insulin patch. This device regulates the dosing schedule for basal and bolus insertions of insulin to maintain the glucose levels of the diabetic patient at a healthy level. The insulin patch is designed to hold a 2-day supply of insulin.
Key advantages of the U-Strip/Insulin system include:
– Very rapid glucose reduction. Volunteers average between 10 and 30 mg/dl reduction in just the first 5 minutes
– Steady glucose reduction to healthy normal range, 95-115 mg/dl followed by glucose stabilization
– Defeats glucose spikes post meal
– Diagnostic & Self Correction
– Dose reporting to physician via the Internet
– Dose tracking memory
– Improved compliance
– Improved disease treatment and management
– Totally non-invasive: needle-free, no catheters
Q: What is the next critical milestone for TSI?
A: The Phase III trial for the insulin system is about to start in 4 nations. Once that data is in, the next critical milestone will be regulatory submission and commercialization for the insulin system. Initially, the target market is type 2 diabetics, to be followed by type 1, and then an insulin patch for children. Along the way through our drug screening program, we will be testing other pharmaceutical compounds for ultrasonic transdermal delivery. Through cooperative research and strategic alliance relationships, we will actively work to expand the number of drugs that can be delivered transdermally, from less than 30 today, to 175 investigations within the next 3 years. Already we are working our way through CNS indications and soon will be investigating arthritis and cardiac care applications.
Q: Will you offer co-development programs with interested potential partners?
A: Yes, we are active in both internal areas beyond insulin, and we do have co-development partnering opportunities for future drug programs. Our drug screening program is expected to generate other opportunities for expanded transdermal applications. First, we treat the target compound for 8 hours using our alternating ultrasound transmission. If no damage, we move to patch development and liberation tests, followed by cadaver skin permeation studies. The whole drug screening investigation can take as little as 3 months. If the compound fails along the way, the partner has invested only in laboratory screening services. If we pass the drug screening program, human clinicals are next, and partners are offered strategic alliance options. As each opportunity manifests itself, we may create separate focus divisions or affiliations to bring those products to market. Right now, insulin has spun to a dedicated subsidiary under Transdermal Global. The CNS, arthritis, cardiac, and oncology products may each be similarly situated depending upon the needs of potential partnerships.
Q: What are the future plans for the enterprise?
A: Insulin is number one on the runway. As previously mentioned, we have created a subsidiary, Transdermal Global, to focus only upon diabetic care products, starting with the type 2 glucose control system, the U-Strip controller, and the low profile Trans-InsulinTM Patch. That subsidiary will be manned by professionals with diabetes care as their sole focus. Essentially, we are placing all of our diabetes researchers, marketing, and clinical teams under one focus – diabetes care. I am a full believer that emergent companies need to have a focus and thus we have placed our diabetes care unit under one roof. Transdermal Global is forming now and expects to enter Phase III clinical trials later this year. A major goal for this year beyond the Phase III trials is to expand our current pilot patch production facility to 1 million patches per week. Meanwhile, the parent company TSI, will continue its product development activities to explore the use of this patented technology to both speed the regulatory review process by avoiding the GI tract, and to expand the number of compounds that can be delivered transdermally. Our R&D teams are working upon several CNS applications, some internally sponsored, and some already with strategic partners. We are now entertaining potential research and strategic partners who may wish to have their compound tested for enhanced transdermal delivery via the U-Strip technology. For inquiries, contact Bruce K. Redding, Jr at (484) 479-3240 or [email protected].
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Transdermal Specialties Global (TSG) Completes a Phase 3 Clinical Trial of the Trans-InsulinTM Transdermal Patch
FREDERICK, Md.
June 10, 2022
the United States
South Korea
Frederick, MD
Brian Butcher
TSG Has Successfully Achieved Maintaining Glucose Levels in Type-2 Diabetic Patients at the FDA Standard of 70% of the time, maintaining the Glucose Range Between 70 and 180 mg/dl, Using the U-StripTM/PRNewswire-PRWeb/ — Transdermal Specialties Global, a pioneer in ultrasonic active patch delivery systems (http://www.u-strip.com), has successfully completed a phase 3 clinical trial of a patented transdermal patch using the U-StripTM transdermal insulin delivery system. TSG conducted a 14-day trial to test the U-StripTM ability to regulate the glucose level in Type-2 Diabetics and meet the Time in Range requirements set by the FDA. The U-Strip is a patented transdermal insulin delivery patch system that uses special ultrasound frequencies to expand the pores of the skin and deliver insulin into the bloodstream No Needles. Insulin is too large to be absorbed by the skin normally. The use of ultrasound dilates the skin pores and pushes the drug into the tissue. Now entering Phase-3 clinical trials in bothand, the U-Strip Insulin system is nearing regulatory acceptance.The Time in Range approach reduced the time for the Phase-3 clinical trial of a Transdermal Insulin patch from 90 days to meet A1C equivalency after just a 14-day study.The results show the trial successfully met both safety and glycemic endpoints and demonstrated no occurrences of severe adverse events, no severe hypoglycemia and diabetic ketoacidosis and no Somogyi Effect.The overall Time in Range (defined as 70-180 mg/dL) was an average of 95%, well over the FDA standard of 70%.The study met primary endpoints (increasing overall Time in Range), as well as secondary endpoints (decreasing overall time above and below range). Patients also reported being extremely satisfied with their experience overall, with 96% agreeing that the system was easy to use and 87% agreeing that the system improved their quality of life.The trial, conducted over 14 days with 6 Type-2 diabetic males, was performed using a combination device containing a special transdermal insulin patch loaded with 75 units of Lispro insulin, a Transducer Coupler and a control device programmed to reduce the starting glucose of the patient to the range of a Healthy Normal non-Diabetic (range of 85 to 110 mg./dl). The control algorithm then stabilizes the glucose level of the patient between 85 and 110 mg/dl. The glucose dropped by 40 points in both subjects in the first 10 minutes and automatically switched to the stabilization setting delivering micro-doses of insulin every minute to maintain the glucose between 85 and 110. The Slower dose setting, deliverers 3.41 units of insulin per hour working like the pancreas, placing minute doses to prevent a rise. This provided superior Time in Range controls for all subjects. The Bolus button delivers 4 units of insulin in 15 minutes to counteract a glucose spike from the meal. The test proved the subject could press the bolus button during the meal preventing the spike and returning the glucose back to stabilization automatically. The system is designed to simplify diabetes management providing an extra layer of protection for the times one may miscalculate their carbohydrates or forget a pre-meal bolus.The study findings at various levels of glucose control, are promising and demonstrate that the Trans-InsulinTM Transdermal Patch using the patented U-StripTM ultrasonic delivery patch system has tremendous potential for meaningfully reducing burden and enhancing quality of life.TSG located inis committed to developing innovative drug delivery systems that enhance health and improve the quality of life. The company has developed an Ultrasonic active patch delivery system U-STRIPTM that uses special ultrasound frequencies to expand the pores of the skin and deliver drugs into the bloodstream…TSG’s first product is a painless Needle-Free transdermal insulin delivery patch system. Since 2016, TSG has been a pioneer in the development of ultrasonic technologies for the pharmaceutical and cosmetic industry., Transdermal Specialties Global, 215-275-4559, [email protected] Transdermal Specialties Global
In Conversation: Bruce K. Redding Jr., CEO of Transdermal Specialties Global · BioBuzz
In Conversation: Bruce K. Redding Jr., CEO of Transdermal Specialties Global
Founded by former NASA mission specialist Bruce K. Redding Jr., Transdermal Specialties Global (TSG) is attempting to revolutionize drug delivery. Redding, who holds over 60 patents, is the inventor of microencapsulation technology, which his company is leveraging to develop an insulin patch as a non-invasive, needleless method for diabetes treatment.
TSG recently demonstrated to the Food and Drug Administration (FDA) that its insulin patch, called the U-Strip™, was able to keep patients’ glucose levels in a safe range over multiple days. The U-Strip will now move into a six-subject trial conducted in the company’s Frederick, Maryland test clinic and, should all go well, move on to Phase III trials once the pandemic subsides in the U.S. The company plans to conduct Phase III trials in South Korea in the near future. TSG also has a patch for Parkinson’s disease that is currently in Phase I trials.
Should TSG’s U-Strip insulin patch be approved by the FDA, it could revolutionize diabetes treatment across the globe by eliminating needles and rendering insulin pumps obsolete, all while delivering superior, less expensive treatment and better quality of life to patients. Redding believes that TSG’s U-Strip insulin patch is just the tip of the iceberg when it comes to TSG’s technology platform’s potential, which could revolutionize drug delivery.
With TSG’s insulin patch nearing Phase III clinical trials, we thought it was a great time to catch up with Redding, who recently relocated TSG to Frederick, Maryland, from Philadelphia, bolstering Frederick’s growing reputation as a key life science sub-cluster in the BioHealth Capital Region’s (BHCR).
What is TSG’s origin story?
TSG’s story starts about 30 years ago, believe it or not. I was working with NASA to develop microencapsulated adhesive tiles for the bottom of the space shuttle. I left the space program and started working on microencapsulation, which I later licensed to DuPont, ConAgra, Nabisco, and a number of other companies. We made the microcapsules using ultrasound.
Every year at Transdermal we have a contest to figure out what else we can use our technology for. The winning team gets a week-long trip to the Bahamas. I came up with the idea of using our technology for drug delivery. Naturally, I didn’t win the trip to the Bahamas because I’m the founder. This was a crazy idea at the time, but we took it to Penn State University and tested it in animal models and that worked. Then we asked what drugs could we deliver?
The theory was that our ultrasound could open your skin pores. All drugs have a molecular size to them. Small molecule drugs are between 0 and 500 molecular weight and your body can absorb them. Between 500 and 1,000 molecular weight you need to do something special that usually involves ‘sandpapering’ the skin in some way. Anything over 1,000 molecular weight you couldn’t put through the skin. 98% of the drugs out there are too large to be transdermally admitted and there are only about 20 patches on the market today that all deliver small molecule drugs.
We realized our technology delivered an unusual effect. I developed a sawtooth wave-combination square wave ultrasound. When the sawtooth wave hits your skin it enlarges your pores, then the square wave inserts the drug through the open pores. We started making microcapsules, which were first used in products like Hamburger Helper and Fruit Roll Ups for flavoring.
Insulin is 6,000 molecular weight and with this ultrasound approach, we can treat people with diabetes transdermally. And there are about 175 other drugs we can possibly target as well. This is how TSG came to be and how the technology I invented has evolved over time into our U-Strip patch platform.
We understand the U-Strip insulin patch just achieved a very important milestone. Where does the insulin patch currently sit within the FDA approval process and what’s next?
The FDA changed its requirement for Phase III for our product. Originally the end target was A1C. Now, with the advent of continuous glucose meters, you can measure glucose levels every five minutes over a number of days. The FDA reduced the length of the Phase III study from 90 days to 14 days because of this. What we had to prove was that 70% of the time our patch kept a diabetic’s glucose range between 70-180 milligrams per deciliter for 14 days.
We conducted a rehearsal study with two participants over six days. Now, we are getting ready to conduct a six volunteer study over 14 days. In our rehearsal study, we beat the FDA standard of 70% of the time-in-range requirement. One patient was 98% and the other was 88% of time-in-range. If you’re a non-diabetic your glucose is between 75-110 and we kept our patients there 80% of the time.
We also looked at mealtime spikes. Diabetics take an injection about 20 minutes ahead of a meal, and many diabetics forget to do this. We found that you could press a button on our device while you’re having a meal and our device delivers 4 units of insulin in 15 minutes and this counteracts any glucose spike during a meal. We also found that the Somygi effect did not occur with our patch during the rehearsal trial. The Somgyi effect is a glucose spike that can impact your eyesight when glucose levels drop overnight. Insulin pumps and injections all have that Somygi effect at 3 or 4 in the morning, and our patch did not. Our patch avoided typical morning glucose spikes as well.
We created our own clinic in Frederick because we couldn’t find any bed space for the volunteers. We needed to create a bubble for our volunteers because of COVID-19. We set this up in December 2020, ran our two volunteer rehearsal, and now we are getting ready for the 14-day FDA trial, which we expect will more than meet the FDA’s standard.
After the 14-day trial, we will apply to enter our Phase III trial that is targeted to include 280 subjects in the U.S. across several clinics, including Johns Hopkins University. Once we conduct this 280 subject trial, and if we succeed, we can apply for FDA approval. In theory, we could get FDA approval next year. However, because of COVID-19 levels in the U.S., it is very difficult to recruit subjects.
We’ve pivoted to conduct our trials in South Korea where COVID levels are low and fewer subjects are required. The plan is to get the insulin patch approved in South Korea over five or six months and then bring this data back to the U.S. And hopefully, COVID levels will be much lower than what they are now and we can pursue a U.S. Phase III trial.
If approved by the FDA, how will TSG’s U-Strip insulin patch positively impact the lives of those suffering from all forms of diabetes?
We used to believe the most important advantage of our product was eliminating needles. In some cases, diabetics have to inject themselves up to five times a day. This is a compliance problem. But now we realize there are quite a few therapeutic benefits, including the potential elimination of eye issues and neuropathy. Our data looks very promising.
A lot of Type-2 diabetics become Type-1s over time because of the strain put on their pancreas because of oral medications. Our patch could remove this problem as well. Also, our U-Strip patch actually gives you insulin; it is not something that fools your body into releasing the insulin you do have. So it might actually prove to be better therapeutically than a needle or an insulin pump.
Our U-Strip patch system is going to make it easier for a diabetic patient to be compliant—all they need to enter their weight, glucose levels, and press a button. It is just really easy to use. In general, we feel our patch has fewer side effects and will be far less expensive for patients than anything that’s currently on the market.
From a cost perspective, our U-Strip insulin patch will provide a more economical option for diabetic patients. We break it down into daily use costs. If you use a needle, you’ll pay $4 to $6 a day; if you use a dial-up needle, the cost is about $16 a day; for an insulin pump, which costs about $7,500 to purchase, translates to about $30 a day.
Our patch daily cost is about $4.50 a day so we are very competitive price-wise.
What is the state of fundraising and scale up for the insulin patch?
Our budget is about $250K to get the product to Phase III. We are currently seeking funding. We previously received funding from MMG out of Baltimore, which helped us move to Frederick, Maryland.
One of our board members was from Akonni Biosystems in Frederick, and they provided us with some lab space. We were founded in Philadelphia, but when we needed a Class 100 clean room, Akonni helped us out. We then created our own clinic in Frederick so we now have two facilities in Frederick.
Production of the patch is done in the U.S. and we have the capability today to produce 1M patches per month. This is not just a research exercise or lab product. We are in the pilot stage right now.
We’re actively reaching out to raise the 250K. Then we will be off to South Korea where we have two shareholders that could help fund the rest of the trials there. There are 9M diabetics in South Korea; the facility that we’ve chosen, Severance Hospital, is also part of the Beijing Diabetes Hospital that has 1.4M diabetics in one clinic. So if we get South Korean approval, we are on the market and saving lives right away.
We are thinking about going public in the future and perhaps expanding our manufacturing capabilities in Frederick, but we need to get these clinical trials done first.
What is the market for transdermal drug delivery and how might it transform drug development and product commercialization in the future?
We’re actively reaching out to Big Pharma companies to see what drugs they might want to test with our technology. For Big Pharma, transdermal delivery systems that bypass the gastrointestinal tract via a patch could reduce the approval process to four to five years, as opposed to 10-12 years and billions of dollars spent. On the aft end, when it comes to patent expirations and generic competition, you could possibly get a 20 year patent extension by switching delivery to a transdermal patch. We’re getting ready now to partner with Big Pharma to explore some of these ideas.
We have 175 other drugs on our target list, some of which make sense and some don’t. Our patch has the most potential for chronic conditions like diabetes, Parkinson’s disease, or MS, and even severe migraines. We are currently conducting a 10 subject Phase I trial for Parkinson’s; our patch for Parkinson’s could potentially knock down tremors that are oncoming and then prevent them from coming back.
In the U.S. alone there are 27M Type-2 diabetics and about 4M Type-1 diabetics. We can make 1M patches per month but that won’t even serve 1% of the diabetic population in the U.S. We plan to sell our insulin patches to Superclinics within Harvard University’s health system that has 300,000 patients, Yale’s clinic with 45,000 patients, the University of Pennsylvania’s clinic with 40,000 patients, and Johns Hopkins’ clinic with about 25,000 diabetic patients. We will aim to convert their needle patients to our patch.
Diabetes in the U.S. is a huge market in and of itself. We are a small company right now—we have about 13 staff members but expect to ramp up hiring once our insulin patch is approved. We are a privately-owned and funded company with no bank debt and no grants. Up until now, we’ve done everything internally and through royalties.
We need to get our insulin patch done first. And if we can get our insulin patch approved, we’ll be letting the world know that there is a new platform and new tool in the tool box for treating disease.
What is your longer term vision for TSG and the U-Strip technology?
I get asked that a lot, ‘What do you want to be when you grow up?’
We’re proving ourselves with our initial trials. Traditionally, we’ve secured strategic alliances with big companies and lived off the royalties. Right now there are just too many possible applications for one small biotech. We’re going to either have to develop joint ventures with the Big Boys and let them run with it. Or we could go public at some point in the future.
We’ve been a patent factory for the first few years; we just secured patent number 62, but now it’s time to get our products out into the market. Right now we are building value by getting through this FDA review. You have to understand that no one has ever done transdermal insulin with the FDA before so we are cutting new ground. We know we’re going to have partners and affiliates moving forward.
Our technology is new and unique—we’re the only company that can deliver drugs over 1,000 in molecular weight through the skin. Our goal is to open up the transdermal market from 20 drugs to approximately 200 at some point in the future.
Transdermal Specialties, Inc.
Transdermal Specialties, Inc. (TSI) is a pioneer in Ultrasonic active patch delivery systems for the drug and cosmetic industries. The Company has developed a patented delivery system that breaks new ground in active patch technology.
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