our people – MedicaMetrix

We have a proven leadership team with years of experience creating successful new companies, launching new medical products and technologies and creating value for early-stage to global 100 companies.

EXECUTIVE LEADERSHIP

MEDICAL ADVISORS

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Christopher G. Lafarge – Chief Operating Officer

Mr. LaFarge is an operationally focused director and executive, with extensive experience as a senior executive in closely held companies including entrepreneurial start-ups, high-growth, and mature organizations. He has also served on the Boards of several privately held corporations, as well as educational and non-profit boards.

He has acquired deep experience in the areas of product development, life sciences, QA systems, and financing. An energetic and outgoing executive who understands business issues and focuses on leading by building relationships and collaborating at all levels.

Mr. LaFarge has provided strategic leadership for early stage, life science, and medical device companies in the fields of urology, anesthesiology, intensive care, and neuroscience as well as companies in the oil and gas, management consulting, and natural resources industries. He has significant experience in raising both debt and equity capital.

Since 2019, Mr. LaFarge has been the COO of Bach Pharma, a pharmaceutical company developing therapeutics for the treatment of neurodegenerative diseases like ALS and Parkinson’s and other life-threatening redox and inflammation-related illnesses like radiation, chemical poisoning, or viral and bacterial infections like pneumonia.

Christopher is also working with an artificial intelligence company in Atlanta GA, IMARC AI, to develop AI-based decision support for ICU/ER physicians as well as other healthcare AI applications.

From 2004-2018, He was the President and CEO of MedicaMetrix, Inc., the predecessor organization to MedicaMetrix LLC where he invented ProstaMetric^®, obtained European regulatory approval (CE Marking certification), and created scalable, manufacturing procedures for the device, and developed a quality management system which received an ISO 13485 certification.

From 1994-2003 he was the CFO and Director of Business Development for IIC, which was created to build and market expert systems, intelligent devices, and control systems for the exploration, drilling, and production segments of the “upstream” petroleum industry.

Christopher also has a wide range of Board experience, working as part of both management teams and boards as well as start-ups and recently capitalized companies with newly organized boards. Mr. LaFarge has an MBA from the Yale School of Management, an MFS in environmental Science from Yale U., and a BA in Biology from Harvard College.

Richard C. Carlson – Executive Vice President – Business Development

Rick Carlson is the Executive Vice President – Marketing and Global Business Development. He returns to the company after having served as the Vice President of International Marketing from 2015 to 2017. In that position, he was responsible for setting up a subsidiary company in the Netherlands and initiated a multi-center clinical trial in the United Kingdom and Europe. Rick identified and built relationships with key urology constituency groups to establish support for the product, and developed support systems to manage distribution, order processing and after-sales service. He also designed clinical protocols for conducting scientific studies including the collection and analysis of data.

Rick has more than 20 years of prostate disease market experience and has been involved in companies focused on the specialty of urology for more 30 years. Rick has proven leadership track record in the US, Europe and other global markets, and he is poised to scaling MedicaMetrix rapidly in both the US, and in international markets. Throughout all of his previous positions, Rick has developed relationships with key urologists and other physicians in major medical centers throughout U.S., Europe and Japan. Prior to MedicaMetrix, Rick served as the CEO of ProUroCare Medical, Inc., a developer of a mechanical imaging device that creates a real-time color image of the prostate.

During the hiatus from MedicaMetrix between 2017 and present, Rick has been serving as the Director of Business Development for a company with an innovative product and technology for eliminating biofilm and other bacteria in water-based facilities. His primary contributions at this company was to develop a U.S. and an international dealer network which resulted in a 65% increase in sales (yoy) in 2019.

Earlier in his career, Rick identified clinical and economic benefits of a range of medtech devices and products, developed requirements for obtaining clinical validation and regulatory approvals in the US and Europe. He also designed training materials and scalable in-service training programs for physicians, and developed product, clinical, regulatory and commercialization strategies for marketing the products.

Rick has created unique medtech device business models, reimbursement strategy, billing models to maximize revenue, acquired and helped submit more than 20 patents to provide a strong intellectual property position. He also helped four medical device companies to develop go-to-market strategies, developed channel and distribution strategies.

His previous urology work experience in the medical device industry includes extended commitments at a gamut of industry leaders such as American Medical Systems, C. R. Bard, Boston Scientific and Advanced Surgical Intervention, Medtronic, and Vicon Systems.

Rick has a BA with honors in Business/Economics from the University of Minnesota, and an MBA with honors in Marketing from the Carlson School of Business at the University of Minnesota.

Nandini Murthy – Principal, Regulatory Affairs And Quality Systems

Nandini Murthy is the Principal, Regulatory Affairs and Quality Systems at MedicaMetrix. She is responsible for all FDA and other product approvals and certifications.

Ms. Murthy has over 20 years of work experience in regulatory affairs, clinical and quality assurance functions with multiple device specialties. She has authored numerous, successful FDA submissions including a de novo, a modular PMA, a HDE, original PMAs, several original IDEs, pre-Submissions, PMA and IDE Supplements and 510(k)s for novel products including implantable devices, sensor/monitoring tools and diagnostic devices.

She has also worked on combination drug-device combination products, regulated by either CDRH or CDER as Lead Review Center, supporting the medical device/CMC/design controls deliverables for FDA submissions. She has experience with product approvals for the EU (CE Mark), Japan and Canadian markets. She has led projects with complex submissions, where she has both managed a team and where necessary, written or executed on the various document deliverables in a hands-on manner. Ms. Murthy has a successful track record of on-time execution and FDA approvals.

In addition to her core expertise in regulatory affairs, Ms. Murthy has designed and executed complex clinical trials and established quality systems to ISO 13485 and FDA Quality System requirements. She has helped early stage and more established larger companies develop their quality systems consistent with their stage of device development. She has experience in developing plans for Quality Systems projects, including tactically prioritizing and directing focus, and updating/communicating plans and status with Management. She has a record of working collaboratively with teams (located both within the US and OUS), building support and consensus towards compliance.

Ms. Murthy served on the Management team of several companies, providing leadership to regulatory efforts, blending a strategic solution-oriented approach with strong tactical abilities. Her work experience in regulatory affairs and quality systems spans a gamut of medical device companies including USCI Division of C.R. Bard, InfraReDx, Cyberkinetics, Aspect Medical Systems, Thoratec and Hologic. Ms. Murthy has served as the key quality systems resource, responsible for developing Quality System to support design/development activities and ensuring that applicable Design History File (DHF) documents were ready for premarket submissions.

Ms. Murthy is a frequent speaker at various clinical and regulatory conferences and meetings. She is a member of the Regulatory Affairs Professional Society (RAPS), Medical Development Group (MDG). She holds an MS in Environmental Science from University of Massachusetts, Boston, and a BS in Chemistry from Bangalore University.

Satish Vankayalapati

Robert J. Rudelius

Christopher G. Lafarge

Richard C. Carlson

Mary Kilwien

Paul Edwards

Jeff Muzzy

Johan Segers

Nandini Murthy

John A. Libertino, MD

Peter N. Madras, M.D.

Mark G. Garzotto, M.D.