Hemostasis in Seconds: Interview with Arch Therapeutics CEO and Founder Dr. Terrence

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Hemostasis in Seconds: Interview with Arch Therapeutics CEO and Founder Dr. Terrence

Hemostasis in Seconds: Interview with Arch Therapeutics CEO and Founder Dr. Terrence **rchi
Medgadget recently covered a tech**logy designed for rapid Hemostasis in response to gunshot wounds. However, bleeding and leaking of body fluids is also a serious risk within the clinic for many surgery and trauma patients. While hemostatic agents*are designed to prevent fluid loss quickly, slow response and high cost can limit the effectiveness and access to existing solutions.*Arch Therapeutics, a Wellesley,*MA-based medical device company, has stepped in to address this need with the AC5*Surgical Hemostatic Device. Currently in preclinical development, AC5 is*designed to achieve Hemostasis when used during both*laparoscopic and open surgical procedures. We had a chance to learn more about this new tech**logy from Dr. Terrence **rchi, the company’s CEO and Founder.

Michael Batista,*Medgadget:*Where did the concept for your new hemostatic agent come from?

[IMG]http://cdn.medgadget.com/wp-content/uploads/2014/05/**rchi-Terrence-Photo-214x300.jpg[/IMG]Dr. **rchi: Bleeding and leaking remain compelling problems to solve at a time when, according to MedMarket Diligence, approximately 114 million surgical and procedure-based wounds occur annually worldwide, including 36 million from surgery in the US. Available hemostatic products possess a combination of troubling limitations: slow onset of action, unreliability, user-unfriendliness, and risk for adverse effects, including healing problems, adhesion formation, infection and other safety concerns. This ongoing and unacceptable situation has opened the door for new products.

We spoke with surgeons, operating room managers, sales representatives for competitive products, and hospital administrative decision-makers regarding their thoughts on what they wanted in an ideal product. Although better efficacy and reliability are important, additional desired product features were identified that have been incorporated into the design of AC5.



Medgadget: How does the AC5 Surgical Hemostatic Device work?

Dr. **rchi: AC5 is a synthetic peptide comprising ami** acids that exist in nature, but which are **t sourced from animals. When squirted or sprayed onto a wound, the clear, transparent liquid promptly intercalates into the **oks and crannies of the connective tissue where it self-assembles itself into a lattice-like gel—a physical structure that provides a barrier to leaking substances. The time to Hemostasis with AC5 based on animal testing to date is measured in a matter of seconds—typically in less than 15 or 30 seconds—rather than several minutes as provided by much of the competition.

**t only is AC5 being designed to induce Hemostasis quickly, it is also designed to conform to irregular wound geometry as it stops bleeding, allow for **rmal healing, help maintain a clear field of vision in the wound area during the surgical procedure, allow surgeons to safely operate through its resulting protective barrier, and be absorbed.

Because it is transparent and neither sticky **r glue-like, it can be ideal for use in the laparoscopic or minimally invasive surgical setting. Physicians, patients, and the industry could one day benefit greatly from AC5 when wounds are created in the body, whether via surgery, trauma, colo**scopy biopsy, device implantation, or in a variety of consumer settings.







Medgadget: What is disruptive about AC5 compared to current practices?

Dr. **rchi: Unlike existing hemostatic agents, AC5 possesses a combination of advantages to benefit wound care specialists and their patients. Based on our work to date, we see evidence that it is laparoscopic-friendly, indifferent to the status of a coagulation cascade or “blood-thinning” *****, simple to prepare and store, **n-toxic, and **n-immu**genic. It is easily applied and handled. Because AC5 is transparent, it can promote a clear field of vision and **t obstruct the surgeon’s view. In fact, a surgeon can operate through it in order to prophylactically stop bleeding as it starts—an important advancement we call Crystal Clear Surgery™. It also flows and does **t seem to cause the problems associated with “glues.”



Medgadget: At what stage is the AC5 tech**logy?

Dr. **rchi: AC5 is in preclinical development. Arch Therapeutics is working through manufacturing scale-up requirements, getting ready for biocompatibility-safety testing, and planning a first-in-human clinical trial.

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Medgadget: What other challenges do you see in current surgical procedures or elsewhere in medical care?

Dr. **rchi: Surgeons’ abilities and techniques are constantly being pushed to the limit, and they respond. Industry is always trying to provide them better tools so that they can do even more for their patients in a safer and more cost-effective manner. The challenge is that tools have **t completely kept up with surgeons, especially in the biomaterials space. I do believe that is changing, but it will take continued vision and commitment from parties with a vested interest to help improve the toolbox.



Medgadget: Are there other areas where AC5 tech**logy can add value?

Dr. **rchi: AC5 can play a beneficial role in a wide range of laparoscopic or minimally invasive surgical procedures. Because this area of medicine is rapidly growing, the value of AC5 should grow accordingly.



Medgadget: Part of Arch Therapeutics’ mission focuses on stasis and barrier solutions. What other tech**logy can we look forward to from the company?

Dr. **rchi: We are focusing all of our efforts on AC5 at this time. We expect to develop other surgical devices for this and other applications in the future. If a hole is made in the body, be it via surgery, trauma or otherwise, we believe there are unmet needs that we might be able to address.



Medgadget: Finally, what is your background, and what makes you excited about the work being done at Arch Therapeutics?

Dr. **rchi: I am President and Chief Executive ******r of Arch Therapeutics, which I co-founded in 2006 and have led from an early stage of research to its current stage of development. Prior to Arch Therapeutics, I was a portfolio manager and pharmaceutical analyst, and head of the healthcare team at Putnam Investments. Previously, I was the senior global biotech and international pharmaceutical equity analyst at Citigroup Asset Management. Prior to that I was a sell-side pharmaceutical analyst at Sanford C. Bernstein in New York City. I earned an MBA from the MIT Sloan School of Management in 1996. I completed my internal medicine residency in 1994 at Baystate Medical Center, Tufts University School of Medicine, where I was selected to serve as Chief Medical Resident. I earned an MD degree in 1990 from **rtheast Ohio Medical University.

What excites me about the development of AC5 is that it holds the potential to make various surgical procedures less risky. For a long time, hemostatic agents with various drawbacks have restricted surgeons. I believe that AC5 possesses a uniquely broad range of benefits that these surgeons and other healthcare providers can harness to their advantage as they seek to always provide even better care to their patients.



Link:*Arch Therapeutics…

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Hemostasis in Seconds: Interview with Arch Therapeutics CEO and Founder Dr> Terrence