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..

新泽西州克罗斯特，2024年2月22日/PRNewswire/--Chemomomouthpoice，LLC.宣布其设备Chemo-Mouthpoice™获得FDA 510（k）上市许可。Chemo-Moutpiece™用于冷却口腔粘膜，以降低成年患者化疗引起的口腔粘膜炎的发生率和严重程度，这是化疗的一种非常令人衰弱的副作用。。

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..

另一条最引人注目的消息是，Chemomomoutpiece，LLC刚刚结束了一轮1000万美元的私募融资，并对超过1000万美元的第二批额外资金作出了全额承诺Chemomomoutpiece总裁兼首席执行官戴维·约斯科维茨（DavidYoskowitz）说，我们在这一轮融资中的合作伙伴不仅提供了必要的营运资金，而且还为邻近的商业部门提供了见识和宝贵的经验。。

'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™.

“Chemo-Mouthopex2122；库存充足，因为我们已经获得FDA的上市许可，下个季度将开始在美国各地发货。我们目前正在执行多管齐下的目标，包括与我们的商业化合作伙伴EVERSANA一起启动和实施一支专门的销售队伍，以及旨在提高对口腔粘膜炎的认识和Chemo-Mouthup™的可用性的重要营销策略。

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.

在口腔粘膜炎领域最重要的思想领袖之一Steve Sonis博士的指导下，我们的临床进步计划进展顺利，因为我们刚刚完成了关键的临床试验。正在起草一份出版手稿，并计划在未来几个月在肿瘤护理学会（ONS）会议，多国癌症支持护理协会（MASCC）会议以及出席今年的美国临床肿瘤学会（ASCO）会议上发表许多演讲，仅举几例。

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..

也就是说，我们的主要举措是增加患者对这种重要产品的使用，并在患者与癌症作斗争时减轻口腔粘膜炎的疼痛和担忧。Chemomomoutpiece，LLC首席商务官弗兰克·雅各布奇（FrankJacobucci）表示，我们很高兴实现了这些最近的里程碑，并期待着将Chemo-Moutpiece™带给数十万可能遭受口腔粘膜炎痛苦和破坏性副作用的患者。。

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

Chemomomoutpiece，LLC是一家私营医疗器械公司，为癌症患者开发和商业化适当的口服冷冻治疗产品。

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..

Chemo-Mouthopex2122；设备是根据发明家、创始人兼首席执行官大卫·约斯科维茨（DavidYoskowitz）的个人经验开发的，他被诊断出患有霍奇金淋巴瘤，并亲身经历了口腔粘膜炎。他的治疗选择包括冰片，以减轻和减少疼痛。然而，这会引起恶心，难以在嘴里保持，并且不能有效地冷却整个口腔，这导致他寻找更好的选择。。

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.

作为一名专业工程师，他把为癌症患者寻找更好的方法来应对治疗期间的口腔粘膜炎作为自己的使命。他发明了一种简单、有效、易于使用的设备，用于家庭或医院的化疗治疗。Chemo Mouthope™可有效冷却整个口腔。

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..

患者可以将设备冷冻在家中，并随身携带，以便在治疗期间使用，从而为未满足患者的需求提供简单的解决方案。。

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.

高达80%的接受干细胞移植的患者和约40%的化疗患者发生口腔粘膜炎。据估计，全球口腔粘膜炎的治疗市场超过数十亿美元，数百万患者受到影响。Chemo-Mouthope™可冷却整个口腔，引起血管收缩，从而减缓并减少口腔中化疗的流量，从而大大降低患口腔粘膜炎的风险。

The cryotherapy approach has been positively studied for decades and the Chemo Mouthpiece™ has significant and improved advantages over conventional cryotherapy interventions..

冷冻治疗方法已经被积极研究了几十年，与传统的冷冻治疗干预相比，Chemo-MouthopeTM具有显着且改进的优势。。

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]

有关Chemomomoutpiece，LLC的更多信息，请访问我们的网站www.chemomoutpiece.com或联系；[受电子邮件保护]的投资者关系/投资银行总监ScottNarins或[受电子邮件保护]的商业运营副总裁BonniTattoli

Media Contact:Frank Jacobucci, Chief Commercial Officer609.330.4949[email protected]

媒体联系人：首席商务官Frank Jacobucci 609.330.4949[受电子邮件保护]

SOURCE ChemoMouthpiece, LLC

来源化学喉舌有限责任公司