ChemoMouthpiece, LLC. Announces the Awarding of the 510(k) Marketing Clearance by the FDA for their Oncology Supportive Care Device and Recent Closing of their Private Placement Round

CLOSTER, N.J., Feb. 22, 2024 /PRNewswire/ -- ChemoMouthpiece, LLC. announces the FDA 510(k) Marketing Clearance for their device, The Chemo Mouthpiece™.  The Chemo Mouthpiece™ is intended to be used to cool the oral mucosa to reduce the incidence and severity of chemotherapy induced oral mucositis in adult patients, a very debilitating side effect of chemotherapy.

In other most notable news, ChemoMouthpiece, LLC. has just closed on their Private Placement Round of $10 million in upfront capital with a full commitment for the second tranche of additional funds in excess of $10 million. "Our funding partners in this round not only provide the necessary working capital but also provide insights and valuable experiences in the adjacent business sectors," said David Yoskowitz, President, and CEO of ChemoMouthpiece.

"Chemo Mouthpiece™ is fully stocked, as we will begin shipping across the US within the next quarter now that we have FDA Marketing Clearance.  We are currently executing multi-pronged objectives including the initiation and implementation of a dedicated sales force with our commercialization partner, EVERSANA, along with important marketing strategies aimed at raising awareness of oral mucositis and the availability of The Chemo Mouthpiece™. Our clinical advancement program under the guidance of Dr. Steve Sonis, one of the foremost thought leaders in the oral mucositis arena, is progressing nicely as we have just completed our pivotal clinical trial. A manuscript for publication is being drafted and numerous presentations are planned for the coming months at the Oncology Nursing Society (ONS) meeting, the Multinational Association of Supportive Care in Cancer (MASCC) meeting as well as attendance at this year's American Society of Clinical Oncology (ASCO) meeting, to name a few. That said, our main initiative is to increase patient access to this vital product and give patients relief from the pain and worries of oral mucositis while they fight their battle with cancer.  We are excited having achieved these recent milestones and look forward to bringing the Chemo Mouthpiece™ to the hundreds of thousands of patients who may otherwise suffer from the painful and disruptive side effect of oral mucositis," stated Frank Jacobucci, Chief Commercial Officer of ChemoMouthpiece, LLC.

ChemoMouthpiece, LLC is a privately held medical device company that develops and commercializes propriety oral cryotherapy products for cancer patients.

The Chemo Mouthpiece™ device was developed based on the personal experience of inventor, founder and CEO, David Yoskowitz, who when diagnosed with Hodgkin's Lymphoma, experienced oral mucositis firsthand. His treatment options included ice chips to mitigate and minimize the pain. Yet this caused nausea, was difficult to maintain in his mouth, and did not effectively cool the entire oral cavity which led him to search for a better option.

An engineer by trade, he made it his mission to find a better way for cancer patients to cope with oral mucositis during treatment. He created a simple, effective, easy-to-use device to be used during chemotherapy treatments at home or in a hospital. The Chemo Mouthpiece™ efficiently cools the entire oral cavity. Patients can freeze the device at home and take it with them to be used during treatment, creating a simple solution for an unmet patient's need.

Up to 80% of all patients receiving stem cell transplant and approximately 40% of all chemotherapy patients develop oral mucositis. The market for the management of oral mucositis is estimated to be in excess of several billion dollars world-wide with several million patients being affected. The Chemo Mouthpiece™ cools down the entire oral cavity, causing vasoconstriction, which in effect slows and reduces the flow of chemotherapy in the oral cavity, thus greatly reducing the risk of developing oral mucositis. The cryotherapy approach has been positively studied for decades and the Chemo Mouthpiece™ has significant and improved advantages over conventional cryotherapy interventions.

For more information on ChemoMouthpiece, LLC, please visit our website at www.chemomouthpiece.com or contact; Scott Narins, Director of Investor Relations/Investment Banking at [email protected] or Bonni Tattoli, VP, Commercial Operations at [email protected] 

Media Contact:
Frank Jacobucci, Chief Commercial Officer
609.330.4949
[email protected]

SOURCE ChemoMouthpiece, LLC