PONTE VEDRA, Fla., Aug. 1, 2023 /PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD) a biopharmaceutical company focused on developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) for certain rare medical conditions, today announced that the Company is expanding its focus for tecarfarin to patients with implanted medical devices for heart diseases who are struggling with the lack of effective anticoagulant treatment options.

Based on clinical data, market research, and insights from key industry experts, the Company believes this approach may be a potential additional indication for tecarfarin.

"The goal for Cadrenal is to advance tecarfarin in targeted indications where Vitamin K antagonists (warfarin) are prescribed yet have failed to achieve sufficiently reliable anticoagulation," commented Quang Pham, CEO of Cadrenal Therapeutics. "Patients with implanted medical devices such as left ventricular assist devices (LVADs) struggle with warfarin due to the way in which it is metabolized, resulting in suboptimal anticoagulation. Tecarfarin is specifically designed to solve warfarin's metabolism problem via an alternate pathway that is abundant and essentially insaturable, providing a much more reliable pharmacokinetic profile. We look forward to expanding our focus for tecarfarin within this patient population."

Based on Cadrenal market research, there are estimated to be 12,000 patients in the U.S. with LVADs who struggle with stable anticoagulation with warfarin. Based on Company estimates, this would translate into an addressable market opportunity of approximately U.S. $600 million per year. The direct-acting oral anticoagulants such as Eliquis and Xarelto are not prescribed for these patients.

ABOUT CADRENAL THERAPEUTICS, INC.

Cadrenal Therapeutics is developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) with orphan drug and Fast Track designations for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease, or ESKD, and atrial fibrillation. Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K antagonist (warfarin) used in the prevention of thrombosis. Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease (CKD). For more information, please visit: www.cadrenal.com.

Safe Harbor Statement

Any statements contained in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." These statements include statements regarding the approach being a potential additional indication for tecarfarin, expanding the Company's  focus for tecarfarin within patients with implanted medical devices for heart diseases, the estimated  12,000 patients in the U.S. with LVADs who struggle with stable anticoagulation with warfarin and the estimated addressable market opportunity of approximately U.S. $600 million per year. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to expand the Company's focus to patients with implanted medical devices for heart diseases, the ability to penetrate the U.S. market for patients with LVADs who struggle with stable anticoagulation with warfarin and the ability to advance patient care in cardiorenal diseases and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2022, and the Company's subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com 

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700,
CVKD@lythampartners.com