Cartiva, Inc., Announces Completion of Patient Enrollment and Treatment in Study of Cartiva® Synthetic Cartilage Implant for Pain Associated with Osteoarthritis of the Thumb

ALPHARETTA, Ga.–(BUSINESS WIRE)–Cartiva, Inc. (Company), a developer of innovative products for treating
cartilage damage and osteoarthritis, announced today that it has
completed enrollment and treatment of all 50 patients in a multi-center
study evaluating the safety and effectiveness of Cartiva Synthetic
Cartilage Implant (SCI) for first carpometacarpal (CMC) joint
osteoarthritis at the base of the thumb. The study was conducted at nine
sites in Canada and the United Kingdom. Basal thumb arthritis is
estimated to afflict more than two million American adults, and up to
one-third of post-menopausal women.

Cartiva SCI is a proprietary biocompatible polymer device designed to
mimic natural cartilage. In July 2016, the Company received Premarket
Approval from the FDA for use of Cartiva SCI in the treatment of
osteoarthritis at the base of the great toe. The thumb implant treats
osteoarthritis in patients with diseased or damaged articular surface in
the first CMC joint. It is implanted in the metacarpal base to replace
damaged cartilage without destroying or removing healthy tissue. The
implant’s design minimizes bone resection while preserving the
trapezium. This may provide a quicker, less painful recovery than
ligament reconstruction tendon interposition (LRTI) surgery or
trapeziectomy.

In late February the Company attended a pre-submission meeting with the
Food and Drug Administration (FDA) to discuss this new indication. The
Company will review the interim six-month results at an investigator
meeting next month.

Mr. Philip Sauve, MB BS, FRCSEd (Tr&Ortho) a Consultant Trauma and
Orthopaedic Surgeon at Queen Alexandra Hospital in Portsmouth, England
who has treated twelve patients with Cartiva, said “So far we have had
good results. Their pain is reducing, their grip strength is increasing
and so their function is improving. These early results are very
promising but we will have to wait to see how the Cartiva implant
performs over a longer period of time. For that group of patients who
are maybe still working and still very active, I think it’s a really
good option.”

“Cartiva SCI for CMC is a unique product that could greatly benefit
patients suffering from this debilitating condition,” said Mr. L.
Christopher Bainbridge, MB ChB, FRCSEd, Consultant Hand and Peripheral
Nerve Surgeon, Pulvertaft Hand Centre, Royal Derby Hospital, and Chief
UK Investigator of the study. “With treatment complete, we are now
focused on patient follow-up and data analysis.”

“Completion of on-time enrollment was an important milestone for the
Company” said Tim Patrick, president and CEO, Cartiva, Inc. “We look
forward to working with FDA to make Cartiva SCI for CMC available in the
United States for this promising indication.”

Osteoarthritis of the CMC Joint

Osteoarthritis of the CMC joint— also known as thumb basal joint
arthritis,—is a debilitating condition impacting 8% to 12% of the
general population and as many as 33% of postmenopausal women. It causes
pain, swelling, instability, deformity, loss of motion and weakness,
making it difficult to perform a variety of tasks, such as turning
doorknobs and opening jars. Current surgical options for later-stage
patients for fail conservative treatments include joint fusion, total or
partial trapeziectomy, arthroplasty, or LRTI (ligament reconstruction
and tendon interposition) which has been done for more than 40 years.

About Cartiva, Inc.

Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative
solutions for patients with cartilage damage and osteoarthritis.
Cartiva’s venture investors include New Enterprise Associates and
Windham Venture Partners. Additional information is available on the
company’s website at www.cartiva.net.

Contacts

Cartiva, Inc.
Peter Pizzo, 770-754-3855
Chief Financial Officer