SafKan Health Announces FDA 510(k) Clearance for First-of-its-Kind OtoSet™ Ear Cleaning System

Automated Ear Cleaning Device Brings Ear Care Into the 21st Century

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Nov 17, 2020, 05:07 ET

HOLLAND, Mich., Nov. 17, 2020 /PRNewswire/ -- Genesis Innovation Group's cultivate(MD) Capital Fund II LP, a fund focused on investments into early stage healthcare companies with innovative technologies, announces that one of their portfolio companies, Tucson-based SafKan Health, a medical device company that has developed the first automated ear cleaning device, the OtoSet^TM Ear Cleaning System has received its 510(k) clearance from the US Food and Drug Administration.

35 million Americans are affected by impacted earwax, a leading cause of conductive hearing loss. OtoSet^TM delivers a safe, quick, effective, and mess-free device to remove impacted earwax. For the last 200 years, the standard of care for removal of earwax has been the Ear & Bladder Syringe. OtoSet^TM, operating on a 35 second cleaning cycle, uses irrigation and microsuction to break down and remove impacted earwax. OtoSet's design makes the device easy to use and clean, and features disposable single patient use ear tips and disposable waste containers. OtoSet^TM brings ear care into the 21st century with the marriage of irrigation and microsuction technology built into an automated and wearable device that offers clinicians unprecedented ease for rapid earwax removal. The unique product has already received two US patents.

"The SafKan Health team is passionate about the innovation they are delivering with the introduction of OtoSet^TM. Receiving FDA clearance shows that the company is able to execute on challenging milestones. I am excited to serve on the SafKan Health Board and to achieve the vision we have outlined together as a team," said Stephen Meyer, former President & CEO of Welch Allyn and a director on SafKan's board.

OtoSet^TM represents a new focus on ear hygiene and health. "As an educator of primary care physicians, I envision OtoSet^TM as an essential tool in patient care," said Dr. Gary Kato, a primary care physician affiliated with the University of Washington Medicine. According to the American Academy of Otolaryngology, excessive or impacted earwax is present in 1 in 10 children, 1 in 20 adults, and more than one-third of the geriatric population. "It seems like such a basic thing, but it's one of the most common reasons people present for hearing-related problems. Patients may try to blindly instrument their ears with cotton ear buds, bobby pins, or other tools. These are generally ineffective and potentially dangerous as scratching of the ear canal skin can lead to pain and infection, and as wax is pushed in further the potential for damage to the ear drum exists," said Dr. Seth Schwartz, an otolaryngologist who led the most recent update of the cerumen (earwax) impaction guideline.

"As an otolaryngologist, we deal with some difficult earwax impactions, and realizing the value OtoSet^TM would have in allowing others to clean out earwax in a safe and gentle manner without the need for a microscope is profound," said Dr. Sapna Patel, an otolaryngologist at Kaiser

R. Sean Churchill, MD, MBA, Executive Director of Genesis Innovation Group said, "The SafKan OtoSet^TM is truly a revolutionary product that solves an ongoing problem for millions of patients with excessive ear wax buildup. Historically the removal of ear wax buildup required a 20 minute procedure by a physician. Now, utilizing the OtoSet^TM, a nurse or trained assistant can complete the same procedure in under 5 minutes."

After an initial clinical launch with primary care physicians and otolaryngologists, SafKan anticipates they will follow with a consumer version that is sold directly to the public. Sahil Diwan, Co-Founder and CEO of SafKan Heath stated, "We plan to do for your ears what electric toothbrushes have done for your teeth. I anticipate the OtoSet^TM will transform ear care."

About SafKan Health:

Founded in 2016, SafKan Health has developed the first automated and FDA Cleared ear cleaning device, OtoSet^TM SafKan Health's clinical advisors include industry-leading primary care physicians and otolaryngologists from the University of Washington Medicine, Kaiser Permanente, Cedars-Sinai, and UCR Health. SafKan Health's investors include Dreamit Ventures, cultivate(MD), PCOM Primary Care Innovation Fund, and the University of Washington. SafKan Health is a TMC Innovation and Creative Destruction Lab alumni company. OtoSet^TM is intended to be used by or with the prescription of a healthcare professional and is not available for over-the-counter purchase. This release also contains forward-looking statements concerning the future launch of SafKan Health's consumer device. Forward-looking statements are based on current expectations for future products and are not guarantees of future performance, development, or FDA Clearance.

For more information about OtoSet, please visit https://www.safkanhealth.com

About cultivate(MD) Capital Funds

As a medical device venture capital fund, cultivate(MD) is dedicated to bringing emerging health care innovations to market, with a special focus on medical device and orthopedic technologies. cultivate(MD) is focused on investing in early stage healthcare companies with innovative technologies that have demonstrated evidence of effectiveness.

This press release does not constitute an offer to sell or solicitation of an offer to buy any securities in any offering of securities. There will not be any sale of any securities in any state or jurisdiction in which such offering, sale or solicitation would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

For more information, visit: https://genesisinnovationgroup.com/

SOURCE Genesis Innovation Group