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LifeMD and Cleared Offer New Hope to Allergy Patients Through Strategic Partnership With Allergenis

2022-08-22 08:00 ET - News Release

NEW YORK, Aug. 22, 2022 (GLOBE NEWSWIRE) -- LifeMD, Inc. (NASDAQ: LFMD), a rapidly growing direct-to-patient telehealth company, today announced that its wholly-owned allergy telehealth subsidiary, Cleared, has entered into a strategic partnership with Allergenis, a predictive data analytics company specializing in the detection and management of life-threatening food allergies.

The strategic partnership leverages Cleared's direct-to-patient allergy telehealth infrastructure and marketing expertise and Allergenis' breakthrough peanut allergy diagnostic blood test. The partnership also establishes Cleared as the exclusive telehealth provider for the commercial launch of Allergenis' highly accurate peanut allergy diagnostic in the direct-to-consumer channel.

The partnership sets a new standard in food allergy management with Allergenis' novel, low-risk and non-invasive peanut allergy diagnostic blood test. This represents a major breakthrough for individuals, their families, caregivers and providers nationwide, with convenient access to crucial peanut allergy answers.

According to an investigation published in the Journal of the American Medical Association Pediatrics (JAMA Pediatrics), an estimated 32 million Americans are affected with food allergy, of which 6 million are affected with peanut allergy. Yet access to allergists specializing in management has become difficult and time-consuming - average wait time for a first appointment is three months. Testing has also become more difficult to obtain, with wait times of up to a year or longer. It is estimated that approximately $25 billion is spent annually in the US on childhood food allergies.

"The Allergenis peanut allergy diagnostic is potentially life-changing for food allergy patients, who have had to rely on a potentially risky and often anxiety-producing procedure called an 'oral food challenge' to rule out a food allergy," said LifeMD CEO Justin Schreiber. "This test fits perfectly with our mission of giving patients convenient access to the care and medications they need to protect and improve their overall health."

The Allergenis peanut allergy diagnostic, which relies on analyzing only a single vial of blood, showed 93% accuracy - without the risk of triggering an allergic reaction that comes with an oral food challenge (OFC).

Considered the standard of care, an OFC requires patients to eat the suspected allergy-triggering food, causing patient reluctance, food aversion, or anxiety. The OFC is thus often difficult to perform or is avoided altogether. Alternatively, the new, non-invasive blood test is a major breakthrough for individuals, their families, caregivers, and providers.

The accuracy rate was previously published in the prestigious peer-reviewed global journal Allergy, the official journal of the European Academy of Allergy and Clinical Immunology (EAACI).

"The Allergenis Peanut Diagnostic is a major step forward in the standard of care for anyone dealing with food allergies," said Dr. Payel Gupta, Medical Director of Allergy & Immunology for Cleared and LifeMD. "The Allergenis Peanut Diagnostic can stratify peanut allergic patients into groups with different levels of reactivity, providing threshold levels to inform a more personalized treatment."

"This represents a potential surrogate for the OFC which is not only time intensive but carries the risk of inducing life-threatening anaphylaxis. I'm excited to see this diagnostic being used to reduce the anxiety and stress involved in diagnosis for children, parents - and everyone. Now, for the first time, patients can access this transformative test via the Cleared and LifeMD telehealth platform without having to wait," she added.

"Through the only nationwide digital food allergy clinic established in partnership with Cleared and LifeMD, together we will deliver novel, precision diagnostic testing," said Jim Garner, CEO of Allergenis. "By making the test readily available, we are addressing a vital unmet need of millions of Americans with peanut allergies."

About the Allergenis Peanut Allergy Diagnostic

The Allergenis peanut allergy diagnostic is the first and only laboratory-developed test service that provides patients their approximate reactivity level to peanuts, one of the most common food allergies. It is a safe CLIA certified diagnostic validated for individuals ages 4 and above.

The Allergenis peanut allergy diagnostic, which relies on analyzing a small amount of blood, resulted in 93% accuracy rate as compared to an oral food challenge without the risk of triggering an anxiety-producing allergic reaction. The study is published in the prestigious global impact journal Allergy, the official journal of the European Academy of Allergy and Clinical Immunology (EAACI).

Concerned parents and interested patients can order the Allergenis peanut allergy diagnostic online through Cleared's telehealth services through this link: https://getcleared.com/product/peanut-allergy-test

The Allergenis peanut allergy diagnostic can be performed from the comfort of one's home. Once suitability for the diagnostic is confirmed by a doctor, patients or parents will receive a blood draw kit, which will be performed by a mobile phlebotomist after the blood draw is scheduled via e-mail or text message. In the case of a child, Allergenis will send a phlebotomist who specializes in pediatric draws. Once results are ready, Cleared will provide an online telehealth consultation to review results and provide treatment or management plans if necessary.

About Cleared

Cleared is a direct-to-consumer telehealth destination that provides end-to-end personalized care for allergy, asthma and immunology. Cleared's strategic partnerships and ever-expanding network of US-licensed Allergists & Immunologists provide patients with fairly priced prescription allergy medications and immunotherapies via its telehealth clinic. For additional information on the Company, please visit its website at http://www.getcleared.com.

About LifeMD

LifeMD is a 50-state direct-to-patient telehealth company with a portfolio of brands that offer virtual primary care, diagnostics, and specialized treatment for men's and women's health, allergy & asthma, and dermatological conditions. By leveraging its proprietary technology platform, 50-state medical group, and nationwide mail-order pharmacy network, LifeMD is increasing access to amazing healthcare that is affordable to everyone. To learn more, go to LifeMD.com.

About Allergenis

Allergenis specializes in the detection and management of life-threatening food allergies. Based on precision, data-driven diagnostics, Allergenis helps healthcare providers safely assess and monitor patients with food allergies and is amassing the world's largest database of phenotypic patient data derived from epitope mapping, clinical history, and patient-reported outcomes. Allergenis was founded via a collaboration with Hugh A, Sampson, M.D., Icahn School of Medicine at Mount Sinai. Allergenis owns and operates a CLIA-certified laboratory in Hatfield, Pennsylvania. For more information, visit allergenis.com, LinkedIn, Twitter, Facebook, or Instagram.

Cautionary Note Regarding Forward Looking Statements

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended; Section 21E of the Securities Exchange Act of 1934, as amended; and the safe harbor provision of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this news release may be identified by the use of words such as: "believe," "expect," "anticipate," "project," "should," "plan," "will," "may," "intend," "estimate," predict," "continue," and "potential," or, in each case, their negative or other variations or comparable terminology referencing future periods. Examples of forward-looking statements include, but are not limited to, statements regarding our financial outlook and guidance, short and long-term business performance and operations, future revenues and earnings, regulatory developments, legal events or outcomes, ability to comply with complex and evolving regulations, market conditions and trends, new or expanded products and offerings, growth strategies, underlying assumptions, and the effects of any of the foregoing on our future results of operations or financial condition.

Forward-looking statements are not historical facts and are not assurances of future performance. Rather, these statements are based on our current expectations, beliefs, and assumptions regarding future plans and strategies, projections, anticipated and unanticipated events and trends, the economy, and other future conditions, including the impact of any of the aforementioned on our future business. As forward-looking statements relate to the future, they are subject to inherent risk, uncertainties, and changes in circumstances and assumptions that are difficult to predict, including some of which are out of our control. Consequently, our actual results, performance, and financial condition may differ materially from those indicated in the forward-looking statements. These risks and uncertainties include, but are not limited to, "Risk Factors" identified in our filings with the Securities and Exchange Commission, including, but not limited to, our most recently filed Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any amendments thereto. Even if our actual results, performance, or financial condition are consistent with forward-looking statements contained in such filings, they may not be indicative of our actual results, performance, or financial condition in subsequent periods.

Any forward-looking statement made in the news release is based on information currently available to us as of the date on which this release is made. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, except as may be required under applicable law or regulation.

Company Contact
LifeMD, Inc.
Marc Benathen, CFO
Email Contact

Investor Relations Contact
Ashley Robinson
LifeSci Advisors, LLC
arr@lifesciadvisors.com

Allergenis Media Contact:
Marla Kertzman
Thoroughbred Communications
marla@thoroughbred-communicaitons.com


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