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A medical device company



Presenter: Mike Daley


Monday, December 10, 2018

Embassy Suites, Chesterbrook, Pennsylvania (directions)




Featuring OrthogenRx:  "Where are they now?"

PCCI revisits companies that have successfully marketed a product or exited a company to learn more about how they reached critical milestones.  Two years ago, OrthogenRx CEO/Founder Mike Daley presented his company at the PCCI "Pitch Perfect" event.  Since then, the company has launched its first product:  GenVisc® 850 to help relieve the pain caused by osteoarthritis.  


More about OrthogenRx

OrthogenRx develops treatments for musculoskeletal conditions including osteoarthritis (OA). The fundamental business model is to license ex-U.S. approved medical devices that are indistinguishable from U.S. approved products, obtain U.S. FDA approval, then commercialize them.  This reduced cost of development and efficient commercialization can translate to reduced cost to the healthcare system and help maintain affordable access to quality healthcare. 


The company’s first commercial product, GenVisc® 850, is a solution of purified hyaluronic acid (sodium hyaluronate; HA) similar to normal knee fluid.  GenVisc® 850 is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen (Tylenol®).  The company estimates the U.S. HA market to be in excess of $1 billion annually.


OrthogenRx submitted its first PMA (Class III medical device approval) just 3.5 months following initial Seed funding in January 2014 that included a BFTP investment with an Approvable Letter in December 2014.  Final approval was received after a full FDA Audit of the domestic and manufacturing facilities (8 days) with no major findings and a full approval in September 2016, just 20 months from initial funding. 


A unique reimbursement code was obtained in November 2015, and a CSO helped launch GenVisc® 850 in late April 2016.  The Company finished the year cash-flow positive in 2016.  In 2017, the Company fully integrated a Commercial Team (Sales, Marketing, Market Access) and finished the year debt-free, cash-flow positive, and $3MM in the bank.  In November of 2017, OrthogenRx received its second FDA approval for TriVisc™ (the first FDA approval in 20 years using a novel regulatory pathway) and is developing a licensed technology for proper placement of intra-articular injections. 


From start-up to a fully integrated commercial company in just 4 years, the Company also just signed another licensing agreement for their fourth product.  The Company has achieved these milestones with only $3.8MM in equity financing.  


OrthogenRx has a talented senior management team with more than 50 years’ experience in the biopharma industry and 30 years’ experience in the development and commercialization of products in the targeted class of medical devices.  The current challenges are to continue to create value for its shareholders, improve commercial efficiencies and market penetration, and compete in a complex market that has become mostly commoditized.



3 Major Issues


  1. How can one best penetrate the managed markets (private insurance) in a mature market?
  2. What is the best strategy to optimize shareholder value:
    1. Organic growth - dividend distibution
    2. IPO (key milestones that would trigger an IPO)
    3. M&A (key milestones that would trigger a M&A)
  3. What is the best model for optimizing commercial success:
    1. Internal sales
    2. CSO and Distributors
    3. 1099 employees (commission based)
    4. Co-Marketing Agreement





6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)

7:45 - Mike Daley, OrthogenRx CEO/Founder, will deliver "Elevator" Pitch to the Group

8:00 - A Panel will address three major issues crucial to helping the Company reach the next level.

9:00 - Open discussion: members and guests




Available Media

Please note: All information obtained here is the property of those presenting and should not be copied or duplicated without written consent.



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The webcast recording of the PCCI meeting is posted on the PCCI website a few days after the event.

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