Medical technology company Lipogems has raised €12.5m in growth capital this year for its knee osteoarthritis (OA) investigational device exemption (IDE) studies, which were approved by the US Food and Drug Administration (FDA).
These FDA studies are related to a separate and specific indication in knee OA.
Lipogems is securing financial resources from ABC Medtech and LIFTT to pave the pathway for a knee OA indication and reimbursement in the US besides building infrastructure to support growth.
The funds will also help educate and raise awareness among consumers and patients about knee OA, and extend into other markets with common conditions that have limited therapeutic options and where MicroFat can deliver better relief.
By taking the support of Mazars and Fantozzi & Ass (financial, accounting and tax matters), Bonelli, Erede and Partners (legal), Nomisma (business), Intexo SB (regulatory), the investors carried out extensive due diligence to validate the regulatory strategy and overall investment in the company.
Lipogems USA CEO and president Carl Llewellyn said: “In this highly regulated field, Lipogems is the proven leader in adipose tissue technologies and is currently being utilised in 250+ US orthopaedic centres and military installations, with 60,000 procedures performed to date worldwide.
“Of the 125+ independent peer-reviewed publications supporting Lipogems, over 35 are in Knee OA and this FDA study will prove the positive results that are commonly seen in this prevalent and disabling condition.”
With a current economic size of $7bn, the osteoarthritis therapies market is anticipated to reach $16bn by 2030.
The minimally invasive procedure of Lipogems is carried out one time in a sterile setting for around 40 minutes.
According to the company, independent and investigator-initiated studies demonstrated that the procedure improved the pain, function and quality of life of patients with knee OA.