Medical Device Development & Implementation

For the past 25 years, Dr. Kavros obtained national and international recognition for the clinical development and commercialization of multiple medical devices. These novel technologies are used in the care of patients with acute and chronic wounds, peripheral vascular disease, diabetes mellitus, mixed connective tissues disease, and the management of fractures, tendinopathies, arthritis of the foot and ankle. The following are the salient medical devices that Dr. Kavros produced and brought to market: 

  • Low frequency ultrasound therapy, MIST Therapy (Cellelation, Inc.)

    • A novel, advanced wound healing technology with superior healing properties with concentration at the cellular and molecular level

    • Developed, managed and performed the basic and clinical science research to validate the novel technology

    • Active participation in the successful regulatory and submission process for FDA approval for the treatment of acute and chronic wound management

    • Direction and guidance to the sales, marketing and commercialization team to deliver the needed education for integrating the technology to physicians, wound centers and hospitals

    • Authorship of multiple peer reviewed publications validating the science and positive clinical and economic outcomes

    • Multiple honors and awards for scientific national and international presentations at conferences/congresses.

  • Pneumatic Compression Device (Aircast, Inc and ArtAssist, Inc)

    • An intermittent pneumatic compression device to manage advanced arterial disease in chronic and acute critical limb ischemia and wound healing for the upper and lower extremities

    •  Developed, managed and participated in clinical trials to assess the efficacy of PCD in patients requiring advanced wound healing in the compromised vascular patient population. 

    • Interfaced with the medical directors of the Medicare Administrative Centers (MACs) to develop a reimbursement pathway for coverage in arterial disease. 

    • The culmination of this initiative resulted in a national reimbursement policy for Medicare and Medicaid allowing a revenue stream for commercialization of a PCD for arterial disease

    • Authorship of multiple peer reviewed publications validating the science and positive clinical and economic outcomes

    • Multiple honors and awards for scientific national and international presentations at conferences/congresses.

  • Aircast Walking Boot, SP Walking Boot, AirHeel (Aircast, Inc., DonJoy, Inc)

    • Aircast Walking Boot:

      • Lowered the platform to relieve low back pain and improve gait biomechanics and offloading

    • Aircast SP Walker:

      • Conceptualized, designed and participated in the development and biomechanics validation of a short leg walking boot for the management of fractures, tendinopathies and arthritis of the foot and ankle

    • Aircast AirHeel:

      • Validated the medical device to manage plantar fasciitis and insertional Achilles tendonitis

      • Authorship of peer reviewed publication validating the science and treatment of this medical devise.

  • PriMatrix (TEI Biomedical, Inc.)

    • A novel fetal bovine dermal xenograft for tissue repair and advanced wound healing

    • Spearheaded clinical research involving the application of PriMatrix in acute and chronic wounds with significant depth, exposure of tendon and bone

    • Developed, managed and preformed clinical research utilizing case series, prospective and randomized clinical trials involving diabetic foot ulcerations using PriMatrix for advanced healing in the high-risk population

    • Directed the sales force in the key components of educating physicians for the maximum outcomes for patient care

    • Spearheaded sales and marketing for the commercialization for PriMatrix into the regenerative medicine arena

    • Authorship of multiple peer reviewed publications validating the science and positive clinical and economic outcomes. 

In addition to focusing on clinical outcomes, Dr. Kavros excels in multiple associated and integral activities that are required for implementation, growth and continued success of a product in the medical device arena. These include but are not limited to:

  • Focused strategic selling with sales and marketing teams

  • Strategic new business development

  • Interactions with C-Suite upper management of hospital systems and insurance companies

  • Policy and reimbursement pathways to ensure financial success

  • Impactful presentations to Centers for Medicare & Medicaid Services (CMS)

  • Successful meetings with key US Congressional members and presentations to US Senate leadership (Washington, DC)

  • Navigating the regulatory process with the FDA leadership for medical device development

  • Development of an integrated, multidisciplinary wound healing practices

  • Implement a best a practice model for utilizing advanced wound healing modalities, xenografts/allograft for both improvement of clinical and economic outcomes