Precision Gynecology: Cosm Medical's Revolution in Pelvic Health

Cosm Medical is modernizing pelvic health through precision gynecological devices to improve the lives of individuals suffering from common and underserved pelvic health issues. Cosm is advancing the standard of care for pelvic floor disorders by introducing the world’s first personalized pessary, Gynethotics™, with FDA and Health Canada market clearances. The accompanying clinic management software and patient education portal streamline clinical workflows, boosting patient outcomes and clinician wellbeing. This patient-centric Digital Gynecology platform integrates AI-driven cloud software and 3D printing to enhance access, quality, and cost of care.

From Personal Experience to Innovation: The Birth of Cosm Medical

The inception of Cosm Medical is rooted in personal experience and professional expertise. Before launching Cosm, Derek Sham, Founder & CEO, worked for a decade creating and commercializing urological products including the most utilized urodynamics system in the world. During that time, his grandmother's life was drastically altered by her pelvic health. Her experience highlighted the urgent need for better solutions, inspiring Derek to create a microcosm of technology dedicated to advancing the macrocosm of female pelvic health.

Innovative Solutions for Pelvic Floor Disorders

Cosm Medical is addressing pelvic floor Disorders (PFDs), which affect half of all women in their lifetime, with a two-part approach: Gynethotics™ Pessaries and a Digital Gynecology Platform.

Gynethotics™ are personalized vaginal prosthetics designed to meet each patient’s unique needs. Traditional dispensaries often fail to provide the needed comfort and fit, with up to 40% of patients unable to find a suitable option. Many successful users of standard pessaries still experience discomfort or complications such as pain, ulcerations, or bleeding. This eventually leads to poor fit or difficulties with self-care at home, leading to high discontinuation rates (over 50% within one year). Gynethotics™ addresses this challenge by offering over ten million variations crafted through 3D printing, ensuring a precise fit with enhanced comfort. To date, Cosm Medical has been able to offer women the hope and reality of a personalized pessary when no standard pessaries were suitable for them and has also increased satisfaction for those women who were wearing a standard pessary but opted for a more comfortable, personalized device.

The Digital Gynecology Platform complements Gynethotics™ by integrating AI-driven cloud software with standardized measurement and patient-centric features. This platform transforms the traditionally fragmented and uncomfortable management of pelvic floor disorders into a seamless, supportive journey. Their solution promotes better outcomes and higher satisfaction much like the advanced and established market of custom dental, orthopedics, and orthotics.

Their software includes a Clinic and Patient Portal to improve patient education, compliance, and health progress monitoring. Through a comprehensive approach and leveraging a patient-centered portal, their Digital Gynecology Platform delivers data-driven therapeutics, ensuring continuous engagement and support for chronic pelvic health conditions, preventing them from worsening without treatment.

Tackling the toughest Challenges in Pelvic Health

•  Data Scarcity and Research: Women’s health has long suffered from a lack of robust data and research. Cosm Medical has tackled this by initiating large-scale studies and partnering with academic institutions to address the data gap. Leveraging machine learning, Cosm derives meaningful insights from the collected data, paving the way for more personalized solutions.

•   Personalized Devices: Personalizing a device for the dynamic and soft tissues of vaginal anatomy is complex. Cosm developed novel measurement tools to improve accuracy and standardize the collection of anatomical data. This data informs the design and 3D printing of personalized vaginal prosthetics.

•   Stigma: Pelvic health issues are often shrouded in cultural and societal stigma, hindering awareness and reporting. Cosm is committed to raising awareness and sharing expert educational content to break these barriers and improve access to pelvic health.

Cosm Medical’s Recent Achievements

•  MDSAP certification, shows their commitment to meeting the highest standard for medical device manufacturing and quality systems, ensuring the safety and efficacy of their products.

•  Regulatory Approvals: FDA and Health Canada market clearances forGynethotics Pessaries allowing us them bring their innovative platform to patients across North America.

•  Pilot study completed with improved satisfaction in all patients, and the publication in the peer reviewed Urogynecology journal has gained support from an editorial published in the same by the American UroGynecology Society(AUGS).

•  First Gynethotics™ users, fitting the unffitable: Cosm Medical is proud to share that they have served their first patient who was not a candidate for surgery and could not find an off-the-shelf pessary that worked for her. Her feedback was: “Gynethotics is magical.” In parallel, one of their patients has received confirmation of health benefits insurance coverage for a Gynethotics™ pessary, indicating a positive trend towards wider reimbursement acceptance.

•  Launching new partnerships expanding Gynethotics™ Pessaries to Gynethotics™ Recovery: They are building their clinical evidence to launch Gynethotics™ Recovery, which utilizes AI and 3D printing to create precise gynecological devices to aid in post-surgery and post-partum recovery.

About Derek Sham

Derek has over 15 years of experience in medical devices. He launched 8+ products including the most utilized urodynamics system in the world used by thousands of urologists on hundreds of thousands of patients culminating in a successful PE-backed exit as a general manager in 2016. He was part of a leadership team as global market director and general manager that scaled a medical device company for eight times return on capital at $640M exit valuation within 4 years. Derek left a high quality corporate MedTech job post-acquisition to create a purpose and profit motivated start-up in women's health that is secured >$9M in investment and non-dilutive funding to modernize female pelvic health.

‍In conversation with Founder Derek Sham

Future trends in the industry

•  Advancing Diagnostics with AI: Integrating AI-guided diagnostics and therapeutics into pelvic health care. Cosm Medical’s platform utilizes machine learning algorithms and decision support tools, providing clinicians with insights that inform personalized care plans.

•  Remote Patient Monitoring and Telemedicine: Increasing adoption of virtual care for improved patient access and cost reduction.

•  Personalized Care: Providing individualized treatment plans and devices using 3D printing. Personalized medicine is not only about tailoring cancer treatments based on individual genetic profiles, but also providing physical devices that are made specifically for each patient, corresponding to their unique anatomy and needs, which has become possible with 3D printing.

•  Additive Manufacturing: The manufacturer of Invisalign for dental precision care is currently the largest user of 3D printing globally, and we see increasing use of 3D printing to create custom prosthetics, implants, and even tissue and organs.

•  Femtech Innovations: Continued growth in women’s health, including pelvic health, which has been under-funded for decades, and now is being supported by government initiatives and funding. Cosm Medical is proud to be at the forefront of this new wave of innovations to improve an underserved field.

Advice for aspiring innovators

Seek out professionals “who have done it before.” In medical device development, there is no room for improvisation due to its complexity. Partnering with those who have successfully navigated this path ensures they know how to optimize your chances of success.

The Role of Tech4Eva

The Tech4Eva program is a great help for our company, opening doors to the European market, facilitating invaluable external feedback, and fostering essential connections. We are excited about the opportunities ahead!

In conclusion, Cosm Medical is not just a company but a mission-driven initiative dedicated to improving women’s health through innovative and accessible gynecological solutions. With continued advancements and support from programs like Tech4Eva, Cosm Medical is well on its way to making a significant impact in the field of pelvic health. Beyond pessaries, Cosm is pioneering a new product category in gynecology to improve the continuum of pelvic care from obstetrics to elderly care ushering in an age of Digital Gynecology.

More Info: www.cosm.care

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