Industry Spotlight: Nissim Mashiach, Macrocure

  OWM: Please describe the education, training, and work experiences that have prepared you for your current position as President and CEO of Macrocure.
  I have worked for numerous small- to large-sized local and multinational companies.   I consider myself a serial entrepreneur and have held senior level positions in 3 companies throughout multiple stages of their development — startups, companies seeking capital funding or going through an Initial Public Offering, and one company that eventually was acquired by a large, multinational Fortune 50 corporation.

  OWM: Why did you choose to take a leadership role with Macrocure?
  I enjoy discovering technologies in large and growing markets where there is a clear, unmet medical need. I was attracted to Macrocure’s technology and that its lead product candidate, CureXcell, has shown clinical and commercial success in Israel. Unlike other biotechnologies that have binary outcomes, CureXcell has treated more than 5,000 patients. This convinced me the technology is working. I identified an opportunity to grow the company by bringing CureXcell to commercialization in the United States, Europe, and the Far East. I believe CureXcell can affect the lives of millions of patients around the world who are seeking a new and innovative treatment that can positively impact their quality of life.

  OWM: What do you like most about working there?
  Our product, CureXcell, has the potential to change the advanced wound care market and offer a novel and proprietary treatment alternative to physicians and patients that could change how chronic and hard-to-heal wounds are treated. Due to our deep knowledge of cell separation, my vision is CureXcell will become a platform technology and not just a wound care product. Our activation process leads to the production of many growth factors. This may be able to affect many types of tissues; if so, this can open the door to new indications, thereby positioning Macrocure as a tissue regeneration company. I believe wound care is the first stage in our development and may lead to many other opportunities in the near future.

  OWM: What makes you the most proud of Macrocure and their employees?
  Our employees have a relentless determination to see the business, the wound care industry, and each other prosper. It is often said that a company’s people are its greatest asset, and Macrocure is no exception.

  OWM: What are some of the company’s biggest accomplishments thus far?
  Most notably, it has been able to initiate 2 pivotal, double-blind, controlled Phase III clinical trials in the US. We also successfully completed an IPO in July 2014, which secured the capital we need to complete these trials and fund the company’s development toward commercialization.

  OWM: What differentiates Macrocure from its competitors?
  Our product offers value creation to patients, physicians, and payers that may never have been seen before in wound care. We have the opportunity to provide a cost-effective solution coupled with a robust set of clinical data generated from more than 500 patients in 2 double-blind studies. We believe CureXcell is a true biological product within the wound care space. We also believe we are the first to test the biological components in our product to determine and ensure the activity and potency of these key elements throughout the shelf life of the product. Currently available therapies are costly for the health care system and cumbersome for the patient due to the multiple applications. Our intention is to bring a once-a-month injection of human, living cells that combines ease-of-use, tailored fill sizes, and attractive economics for the health care system, hospitals, and physicians.

  OWM: What is the biggest challenge you face working in the realm of wound care?
  The wound care industry has developed a reputation for being the “Wild, Wild West” and has seen more failures than successes. As a result, we aren’t yet getting the attention and validation we think is warranted. However, we are confident that with time, our track record in Israel and the data we hope to generate from our US clinical trials will allow us to change the landscape for advanced wound care and change the way chronic and hard-to-heal wound are treated.

  OWM: In what direction would you say the industry is moving?
  The wound care industry is undergoing increased regulatory and reimbursement scrutiny. Companies are being asked to pursue a more rigorous regulatory path, such as a Biologics License Application (BLA), which entails conducting more rigorous clinical trials. In addition, the reimbursement landscape has changed. Products are being mandated into a high-cost or low-cost bundle and product waste is under scrutiny and not well tolerated. We feel Macrocure is well-positioned in this new landscape — we are pursuing a BLA and, because of the liquid formulation, we intend to manufacture different fill sizes that would match wound size, thereby reducing product waste.

  OWM: How does Macrocure remain competitive in the wound care field?
  It’s a combination of a few factors. First, the innovative, once-a-month injection is unique in terms of encouraging patient compliance and the ease-of-use it provides for the physician. Second, the compelling, robust clinical data we are generating attracts physicians seeking both a new treatment alternative for their patients and evidence-based medicine. Last, we intend to price our product to suit the reimbursement environment and provide attractive yet reasonable economics to hospitals and physicians.