Aveta Medical Ltd

AVeta Medical, a Galway based company, are developing an innovative handheld device (VITA AV) directed towards a number of clinical indications for the treatment of Genitourinary Symptoms of Menopause, (GSM) previously known as Vaginal Atrophy (VA). 

The AVeta leadership team is an experienced dedicated group working to achieve the goal of delivering the first non-hormonal medical device technology for the treatment of the GSM. Working closely with a team of practicing Urogynaecologists and Medtech veterans with significant knowledge,  understanding and networks of clinical practice and the Medtech space.

Current standard of care is vaginal hormonal treatment, many women won’t or can’t use it. Clinicians don’t offer it in many cases due to patient’s medical history, (breast cancer, heart disease)  therefore making it unsuitable for large segments of the menopausal population. For those that do use it there are significant limitations due to compliance issues, irritation and impact on their lives overall. Other energy-based offerings such as laser and radiofrequency 

therapies are being used, however this is off label, unapproved use and not paid for by the insurance companies

VITA AV is a non-hormonal easy to use device, with 4 easy to administer 5-minute procedures, women can get up to 10 months symptom free. Based on the principles of negative pressure wound healing, the device creates micro injuries, restoring the tissue health to its pre menopause state.  Easy to use, easy to teach enabling physicians to delegate treatment to nurse practitioners , and physicians assistants .

AVeta Medical’s philosophy to deliver the first approved non hormonal treatment for GSM, is to pursue regulatory approval and reimbursement in key markets making it accessible to more patients. In the US, the regulatory path will be a De Novo application, in addition to submissions under Breakthrough Device Designation (BDD) to enhance reimbursement under the Transitional Coverage for emerging technologies (TCET).

AVeta Medical have achieved a first in human feasibility study with 12 month follow up, which significantly derisks the technology. A pilot study is planned for late 2025. Upon receiving interim results, it is planned to reach out to 2 Strategic partners, to invest with a view to exit. 

Revenue Projections are estimated at EUR 70m to EUR 268m, 3-5 years , GM 83% . 

Go to market strategy in the US will be AVeta Medical direct to physician and EU will be Third Party Distributor model. In both geographic regions education and awareness programs to prescribing physicians and women are planned.