(News Bulletin 247) – After erasing most of its value since its IPO, Implanet regained a little height on Tuesday thanks to the approval of the Squale range of cervical cages by the FDA in the United States.

Implanet is starting this new stock market week (shortened by a day) by prancing ahead of the biggest increases on the Parisian market. The action of the medical technology company soared 31% to 0.225 euro around 11:10 a.m., after the announcement of the approval in the United States by the Food and Drug Administration (FDA) of its anterior cervical cage Squale. Despite the day’s rebound, the Implanet share has posted a heavy loss since its IPO in November 2013, based on a price of 7.20 euros per share.

While the main product of the Gironde company remains the Jazz implant, Implanet has also expanded its range intended for spine surgery with the acquisition in May 2021 of the company OSD (Orthopaedic & Spine Development), which also specializes in the design, manufacture and sale of implants intended for spinal surgery.

And nearly two years after the acquisition of its French competitor for 4.2 million euros, the first synergies between the two companies are beginning to materialize. The FDA approval of the Squale line of anterior cervical cages follows the first surgeries in the United States performed in 2022 with the Origin cervical plate, another product in the OSD line. These first interventions with the Origin plate “then marked the first success of the merger between Implanet and the company OSD”, recalls the French medtech.

“This new approval once again demonstrates the full potential of the synergies offered by the range of products from the OSD portfolio and is fully in line with our strategy aimed at boosting our presence in the United States”, says Ludovic Lastennet, CEO of Implanet.

A cervical cage makes it possible “to preserve the space between the vertebrae and to set up the bone graft in it so that the patient’s body sticks the vertebrae between them. This bone graft is made up of the patient’s natural bone or bone synthetic”, specifies on its site the Espace francilien du Rachis Paris, which brings together several French doctors specializing in spine surgery.

Marketing of Squale before summer 2023

This approval by the American health authority thus gives the green light to the marketing of this range of anterior cervical cages. The launch of Squale cages in the United States is thus planned before the summer of 2023. To date, more than 15,000 cages from the Squale range have been installed throughout the world.

“This is a new structuring step for our development plan in the United States, aimed in particular at strengthening our offer in the field of spinal surgery on a market estimated at 1.35 billion dollars”, adds the manager. . “In 2023, the group intends to capitalize on this merger to revitalize its presence in the United States”, recalls Invest Securities in its note of the day devoted to French medtech.

Implanet is counting on this new regulatory success to strengthen its presence across the Atlantic. Especially since the company has indicated that it is having difficulty obtaining the precious CE marking, which is now directly granted by Europe and no longer by the French administration. “The cost of submission per file has been multiplied by four and now amounts to 100,000 euros. Therefore we are now thinking of launching our new products in the United States where it is easier to obtain the agreement of the American FDA”, has said Ludovic Lastennet at Echoes.

A partnership with Sanyoy Medical in China

The company is therefore expanding internationally, particularly in China, the world’s largest market in volume for spine surgeries. And it’s been done since June 2022. Implanet then joined forces with Sanyou Medical, a Chinese manufacturer of medical devices for spine surgery. As part of this partnership, medtech will market its range of Jazz spine implants in China, through a distribution contract with Sanyou Medical.

The registration with the Chinese health authorities of Implanet’s proprietary Jazz range is still in progress. The two partners also plan to develop a new European range of hybrid fixation including the latest advances and innovations in spine surgery.

Financial support from Sanyou Medical also completed this strategic and technological partnership. The Chinese group took a stake in the capital of Implanet, in the amount of 5 million euros, by means of a capital increase with maintenance of preferential subscription rights. This fundraising aims to help Implanet to “pass a new course and calmly envisage a turnover allowing it to reach financial equilibrium in the medium term” indicated the company last October.

Despite growing adoption of its equipment by surgeons, the group has not recorded any profitable exercise since its creation. If the medtech saw its activity increase by 31% to 8.03 million euros in 2022, the net result for the same financial year still remains in deficit at the level of 3.54 million euros, against a net loss of 3, 09 million euros charged in 2021. The company will provide an update on its activity for the 1st quarter of 2023 on April 25, 2023 after trading.