The board of directors of SomnoMed has appointed Amrita Blickstead and Karen Borg as joint chief executive officers (CEOs) and executive directors of SomnoMed, a company specializing in oral appliance treatment solutions for sleep-related breathing disorders and obstructive sleep apnea

They will succeed Neil Verdal-Austin, who advised the board of his resignation after serving the company for 15 years, 10 years as its chief financial officer and five years as CEO.

Blickstead and Borg have served as non-executive directors of SomnoMed since 2020, thereby bringing a current and comprehensive knowledge of the company, as well as a breadth of skills and experience, according to a release from SomnoMed. 

Borg is a leader with a career in the global medical devices sector. She has led major businesses within Johnson & Johnson Medical and ResMed, as well as health and industry organizations for state and federal government. Most recently, she was the CEO of Catholic Healthcare, an aged care provider in Australia. Borg’s core capability is in sales and marketing of medical devices. She has had a strong track record of accelerating growth internationally in the United States, Europe, and APAC. 

Blickstead brings monetization expertise to the company through her track record of driving operational efficiencies and revenue growth. As the former chief operating and marketing officer at eBay Australia, she led many critical functions including sales, marketing, pricing, strategy, and operations. Her career began in medical devices as a biomedical engineer at Cochlear and Ventracor. She has an MBA from Harvard Business School. 

The co-CEO leadership structure enables a wealth of experience, complementary skill sets, and increased focus across different geographies and functions, which will enable SomnoMed to improve its growth trajectory, according to a release from the company. 

Borg will spend time in both the United States and Europe, responsible for global sales revenue across all regions. Blickstead will be based in Sydney and responsible for corporate, operations, global marketing, and product development. 

“I am confident that both Karen and Amrita will be able to contribute greatly to the future global development of our company,” says Guy Russo, chairman of SomnoMed, in a release. “The board is greatly appreciative of Mr Verdal-Austin’s leadership of SomnoMed and his dedication over the past 15 years. During his tenure as CEO, SomnoMed passed a milestone of treating over 850,000 patients across 28 countries. Mr Verdal-Austin was a pioneer for new product innovation, having laid the pathway for our next-generation RestAssure technology and digital manufacturing processes.” 

SomonMed’s Quarterly Results

SomnoMed also provided its quarterly activities report for the period ended Dec 31, 2023, reporting that the total number of patients treated by SomnoMed worldwide now exceeds 860,000.

SomnoMed’s core business was interrupted during the second quarter of FY24 with the unplanned and unexpected milling machine downtime, reducing the growth run rate from 15% in the first quarter to 11% in the second quarter. All issues have been resolved, and the manufacturing capacity has returned to 100%, according to the company.

Q2 FY24 North American revenue rose +7.7% (+6.6% in constant currency) versus the previous comparable period. The “disappointing” results seen in Q2 were heavily impacted by the lagged delivery of finished goods due to the milling machine downtime. Planned sales for the quarter were lost to competitors during this final quarter of the insurance year. 

At the same time, the SomnoDent Avant sales continue to be impacted by the awaited Medicare reimbursement coding. A new submission was made to PDAC during the quarter, which included new additional information requested.

SomnoMed remains confident that patients and physicians are looking at oral appliance therapy as an alternate treatment path for mild and moderate obstructive sleep apnea patients.

As previously announced in Q1 FY24, the 510k US Food and Drug Administration (FDA) regulatory filing for the Rest Assure technology in the United States was completed and submitted in October 2023. The submission is currently being reviewed. We anticipate an initial response from the FDA during Q3.

Commercialization of Rest Assure in the United States will commence once FDA approval is received. Due to the different regulatory classifications within Europe, the first sales of Rest Assure in Europe are expected when all end-to-end manufacturing quality processes are complete; this is expected in early Q4 FY24.

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