Drug-Free, Faster, and More Effective Cure of Vaginal Infections

ABOUT COOLOGICS

First, drug-free, faster, and more effective treatment of vaginal infections, clinically proven

Safe, tampon-like device stops symptoms immediately

Antibiotics work poorly and are slow, contribute to antibiotic resistance that is causing drug failures, recurrent infections, and deaths in the immunocompromised.

Vaginal Infections are linked to preterm births. Treating vaginal infections in pregnancy lowers preterm births substantially.

Recurrent infections contribute to lost productivity that costs up to $39M per year.

Invented by a female OB/GYN who is a recurrent sufferer and had a preterm birth.

FAQs

What Conditions Does the Device Treat?

Vaginal yeast and bacterial infections  such as Bacterial Vaginosis. Yeast infections cause intense itching, burning, swelling, and pain while bacterial infections cause a discharge with an odor, irritation, or minor itch.

How Does the Device Work?

The safe proprietary, patented materials address multiple mechanisms of action including physical and mechanical interactions with the vaginal wall, time-controlled cooling that treats the infection, stops symptoms, promotes the microbiome & pH, and breaks up biofilms. Biofilms make the infections hard to treat.

How Effective is it?
Almost 100% clinically proven.
Why Does it Cure Better than Drugs?
Drugs only target ONE specific aspect of the infection (the yeast or bacteria) leading to high failure rates (only 30-70% effective). This leads to reinfections and and drug resistance problems which are deadly to people with suppressed immune systems. Our device targets FOUR aspects of the infection such as the yeast and bacteria, the inflammation, pH, and biofilms.
Is the Device FDA Approved?

Not yet, but the FDA has recommended it as a ‘Breakthrough’ Class II Device–like tampons and menstrual cups. A larger clinical trial will be needed for FDA approval. It is considered a low-risk, safe device, with no risk of adverse effects. Over 30 women have used the device safely and successfully.

Not available for sale.

USER REVIEWS

THE TEAM

Kim Langdon, MD.

Founder/CEO

Founder/Inventor 19-years as Board-Certified OB/GYN

MD, The Ohio State University (OSU)

OB/GYN Residency OSU; 98th

Percentile (CREOG)

Senior Research Award 1st Place

Author of two granted patents, 4 patents pending

Establishing US market strategy,

Negotiating partner agreements,

Recruiting and leading executive team of industry professionals.

Cynthia Pritchard PhD

Chief Regulatory Officer

Leading FDA Expert

Brought more than 40 Class II and Class III devices from R & D through clinical trials, manufacturing, to FDA-approval,

Developing quality systems and preparing regulatory submission.

Wrote 50 successful submissions to CDRH and CBER of the FDA.

BS in microbiology: University of South Florida,

PhD in virology/molecular biology at Virginia Tech, Postdoctoral Fellow in Biochemistry Harvard

Keith Aqua MD

Chief Medical Officer

Board-Certified OB/GYN

Certified clinical investigator.

Working with CRO to set up clinical trial sites while gaining FDA approval.

Principal Investigator on over 300 pharmaceutical industry sponsored clinical trials.

Extensive research, publications & frequently cited in women’s health

Pharmaceutical company experience

Dale Hunt PhD, JD

Chief Legal Officer

Plant & Planet Law Firm

29-years experience as Medical Device, Life Sciences IP attorney

Secured first and second patent & filed responses to patent applications

Responsible for patent portfolio

UC Berkeley Law Degree; PhD Biology

MDs/PhDs Endorsed

Get In Touch

Dr. Langdon will notify you when the product becomes available if you leave your name and email here. She will send discount coupons at the same time.

Contact Us

kim@coologics.com

1468 W. 9th St.
Suite 100
Cleveland, OH 44113