EX-99.2 3 tm2531129d1_ex99-2.htm EXHIBIT 99.2

 

Exhibit 99.2

 

Orchestra BioMed Business Update November 2025 Nasdaq: OBIO

 

 

Forward - Looking Statements dŚŝƐ ƉƌĞƐĞŶƚĂƚŝŽŶ ŚĂƐ ďĞĞŶ ƉƌĞƉĂƌĞĚ ĨŽƌ ŝŶĨŽƌŵĂƚŝŽŶĂů ƉƵƌƉŽƐĞƐ ŽŶůLJ ĨƌŽŵ ŝŶĨŽƌŵĂƚŝŽŶ ƐƵƉƉůŝĞĚ ďLJ KƌĐŚĞƐƚƌĂ ŝŽDĞĚ ,ŽůĚŝŶŐƐ͕ /ŶĐ ͘ ͕ ƌĞĨĞƌƌĞĚ ƚŽ ŚĞƌĞŝŶ ĂƐ ͞ ǁĞ͕ ͟ ͞ ŽƵƌ͕ ͟ ͞ KƌĐŚĞƐƚƌĂ ŝŽDĞĚ͕ ͟ ĂŶĚ ͞ ƚŚĞ ŽŵƉĂŶLJ͕ ͟ ĂŶĚ ĨƌŽŵ ƚŚŝƌĚ Ͳ ƉĂƌƚLJ ƐŽƵƌĐĞƐ ŝŶĚŝĐĂƚĞĚ ŚĞƌĞŝŶ ͘ ^ƵĐŚ ƚŚŝƌĚ Ͳ ƉĂƌƚLJ ŝŶĨŽƌŵĂƚŝŽŶ ŚĂƐ ŶŽƚ ďĞĞŶ ŝŶĚĞƉĞŶĚĞŶƚůLJ ǀĞƌŝĨŝĞĚ ͘ KƌĐŚĞƐƚƌĂ ŝŽDĞĚ ŵĂŬĞƐ ŶŽ ƌĞƉƌĞƐĞŶƚĂƚŝŽŶ Žƌ ǁĂƌƌĂŶƚLJ͕ ĞdžƉƌĞƐƐĞĚ Žƌ ŝŵƉůŝĞĚ͕ ĂƐ ƚŽ ƚŚĞ ĂĐĐƵƌĂĐLJ Žƌ ĐŽŵƉůĞƚĞŶĞƐƐ ŽĨ ƐƵĐŚ ŝŶĨŽƌŵĂƚŝŽŶ ͘ ĞƌƚĂŝŶ ƐƚĂƚĞŵĞŶƚƐ ŝŶĐůƵĚĞĚ ŝŶ ƚŚŝƐ ĚŽĐƵŵĞŶƚ ƚŚĂƚ ĂƌĞ ŶŽƚ ŚŝƐƚŽƌŝĐĂů ĨĂĐƚƐ ĂƌĞ ĨŽƌǁĂƌĚ Ͳ ůŽŽŬŝŶŐ ƐƚĂƚĞŵĞŶƚƐ ĨŽƌ ƉƵƌƉŽƐĞƐ ŽĨ ƚŚĞ ƐĂĨĞ ŚĂƌďŽƌ ƉƌŽǀŝƐŝŽŶƐ ƵŶĚĞƌ ƚŚĞ hŶŝƚĞĚ ^ƚĂƚĞƐ WƌŝǀĂƚĞ ^ĞĐƵƌŝƚŝĞƐ >ŝƚŝŐĂƚŝŽŶ ZĞĨŽƌŵ Đƚ ŽĨ ϭϵϵϱ ͘ &ŽƌǁĂƌĚ Ͳ ůŽŽŬŝŶŐ ƐƚĂƚĞŵĞŶƚƐ ŐĞŶĞƌĂůůLJ ĂƌĞ ĂĐĐŽŵƉĂŶŝĞĚ ďLJ ǁŽƌĚƐ ƐƵĐŚ ĂƐ ͞ ďĞůŝĞǀĞ͕ ͟ ͞ ŵĂLJ͕ ͟ ͞ ǁŝůů͕ ͟ ͞ ĞƐƚŝŵĂƚĞ͕ ͟ ͞ ĐŽŶƚŝŶƵĞ͕ ͟ ͞ ĂŶƚŝĐŝƉĂƚĞ͕ ͟ ͞ ŝŶƚĞŶĚ͕ ͟ ͞ ĞdžƉĞĐƚ͕ ͟ ͞ ƐŚŽƵůĚ͕ ͟ ͞ ǁŽƵůĚ͕ ͟ ͞ ƉůĂŶ͕ ͟ ͞ ƉƌĞĚŝĐƚ͕ ͟ ͞ ƉŽƚĞŶƚŝĂů͕ ͟ ͞ ƐĞĞŵ͕ ͟ ͞ ƐĞĞŬ͕ ͟ ͞ ĨƵƚƵƌĞ͕ ͟ ͞ ŽƵƚůŽŽŬ ͟ ĂŶĚ ƐŝŵŝůĂƌ ĞdžƉƌĞƐƐŝŽŶƐ ƚŚĂƚ ƉƌĞĚŝĐƚ Žƌ ŝŶĚŝĐĂƚĞ ĨƵƚƵƌĞ ĞǀĞŶƚƐ Žƌ ƚƌĞŶĚƐ Žƌ ƚŚĂƚ ĂƌĞ ŶŽƚ ƐƚĂƚĞŵĞŶƚƐ ŽĨ ŚŝƐƚŽƌŝĐĂů ŵĂƚƚĞƌƐ ͘ dŚĞƐĞ ĨŽƌǁĂƌĚ Ͳ ůŽŽŬŝŶŐ ƐƚĂƚĞŵĞŶƚƐ ŝŶĐůƵĚĞ͕ ďƵƚ ĂƌĞ ŶŽƚ ůŝŵŝƚĞĚ ƚŽ͕ ƐƚĂƚĞŵĞŶƚƐ ƌĞůĂƚŝŶŐ ƚŽ ƚŚĞ ƉŽƚĞŶƚŝĂů ƐĂĨĞƚLJ ĂŶĚ ĞĨĨŝĐĂĐLJ ŽĨ ŽƵƌ ƉƌŽĚƵĐƚ ĐĂŶĚŝĚĂƚĞƐ͕ ƚŚĞ ŝŶŝƚŝĂƚŝŽŶ͕ ĞŶƌŽůůŵĞŶƚ ĂŶĚ ƚŝŵŝŶŐ ŽĨ ŽƵƌ ƉůĂŶŶĞĚ ƉŝǀŽƚĂů ƚƌŝĂůƐ ĂŶĚ ƌĞƉŽƌƚŝŶŐ ŽĨ ƚŽƉ Ͳ ůŝŶĞ ƌĞƐƵůƚƐ͕ ĞdžƉĞĐƚĞĚ ŵĂƌŬĞƚ ƐŝnjĞƐ ĨŽƌ ŽƵƌ ƉƌŽĚƵĐƚ ĐĂŶĚŝĚĂƚĞƐ͕ ƚŚĞ ĂďŝůŝƚLJ ŽĨ ŽƵƌ ƉĂƌƚŶĞƌƐŚŝƉƐ ƚŽ ĂĐĐĞůĞƌĂƚĞ ĐůŝŶŝĐĂů ĚĞǀĞůŽƉŵĞŶƚ ĂŶĚ ƚŚĞ ďĞŶĞĨŝƚƐ ŽĨ ƌĞĂŬƚŚƌŽƵŐŚ ĞǀŝĐĞ ĞƐŝŐŶĂƚŝŽŶ ͘ dŚĞƐĞ ƐƚĂƚĞŵĞŶƚƐ ĂƌĞ ďĂƐĞĚ ŽŶ ǀĂƌŝŽƵƐ ĂƐƐƵŵƉƚŝŽŶƐ͕ ǁŚĞƚŚĞƌ Žƌ ŶŽƚ ŝĚĞŶƚŝĨŝĞĚ ŝŶ ƚŚŝƐ ĚŽĐƵŵĞŶƚ͕ ĂŶĚ ŽŶ ƚŚĞ ĐƵƌƌĞŶƚ ĞdžƉĞĐƚĂƚŝŽŶƐ ŽĨ ƚŚĞ ŽŵƉĂŶLJ ͛ Ɛ ŵĂŶĂŐĞŵĞŶƚ ĂŶĚ ĂƌĞ ŶŽƚ ƉƌĞĚŝĐƚŝŽŶƐ ŽĨ ĂĐƚƵĂů ƉĞƌĨŽƌŵĂŶĐĞ ͘ dŚĞƐĞ ĨŽƌǁĂƌĚ Ͳ ůŽŽŬŝŶŐ ƐƚĂƚĞŵĞŶƚƐ ĂƌĞ ƉƌŽǀŝĚĞĚ ĨŽƌ ŝůůƵƐƚƌĂƚŝǀĞ ƉƵƌƉŽƐĞƐ ŽŶůLJ ĂŶĚ ĂƌĞ ŶŽƚ ŝŶƚĞŶĚĞĚ ƚŽ ƐĞƌǀĞ ĂƐ ĂŶĚ ŵƵƐƚ ŶŽƚ ďĞ ƌĞůŝĞĚ ŽŶ ĂƐ Ă ŐƵĂƌĂŶƚĞĞ͕ ĂŶ ĂƐƐƵƌĂŶĐĞ͕ Ă ƉƌĞĚŝĐƚŝŽŶ͕ Žƌ Ă ĚĞĨŝŶŝƚŝǀĞ ƐƚĂƚĞŵĞŶƚ ŽĨ ĨĂĐƚ Žƌ ƉƌŽďĂďŝůŝƚLJ ͘ ĐƚƵĂů ĞǀĞŶƚƐ ĂŶĚ ĐŝƌĐƵŵƐƚĂŶĐĞƐ ĂƌĞ ĚŝĨĨŝĐƵůƚ Žƌ ŝŵƉŽƐƐŝďůĞ ƚŽ ƉƌĞĚŝĐƚ ĂŶĚ ŵĂLJ ĚŝĨĨĞƌ ĨƌŽŵ ĂƐƐƵŵƉƚŝŽŶƐ ͘ DĂŶLJ ĂĐƚƵĂů ĞǀĞŶƚƐ ĂŶĚ ĐŝƌĐƵŵƐƚĂŶĐĞƐ ĂƌĞ ďĞLJŽŶĚ ƚŚĞ ĐŽŶƚƌŽů ŽĨ ƚŚĞ ŽŵƉĂŶLJ ͘ dŚĞƐĞ ĨŽƌǁĂƌĚ Ͳ ůŽŽŬŝŶŐ ƐƚĂƚĞŵĞŶƚƐ ĂƌĞ ƐƵďũĞĐƚ ƚŽ Ă ŶƵŵďĞƌ ŽĨ ƌŝƐŬƐ ĂŶĚ ƵŶĐĞƌƚĂŝŶƚŝĞƐ͕ ŝŶĐůƵĚŝŶŐ ĐŚĂŶŐĞƐ ŝŶ ĚŽŵĞƐƚŝĐ ĂŶĚ ĨŽƌĞŝŐŶ ďƵƐŝŶĞƐƐ͕ ŵĂƌŬĞƚ͕ ĨŝŶĂŶĐŝĂů͕ ƉŽůŝƚŝĐĂů͕ ĂŶĚ ůĞŐĂů ĐŽŶĚŝƚŝŽŶƐ ͖ ƌŝƐŬƐ ƌĞůĂƚĞĚ ƚŽ ƌĞŐƵůĂƚŽƌLJ ĂƉƉƌŽǀĂů ŽĨ ƚŚĞ ŽŵƉĂŶLJ ͛ Ɛ ƉƌŽĚƵĐƚ ĐĂŶĚŝĚĂƚĞƐ ͖ ƚŚĞ ƚŝŵŝŶŐ ŽĨ͕ ĂŶĚ ƚŚĞ ŽŵƉĂŶLJ ͛ Ɛ ĂďŝůŝƚLJ ƚŽ ĂĐŚŝĞǀĞ ĞdžƉĞĐƚĞĚ ƌĞŐƵůĂƚŽƌLJ ĂŶĚ ďƵƐŝŶĞƐƐ ŵŝůĞƐƚŽŶĞƐ ͖ ƚŚĞ ŝŵƉĂĐƚ ŽĨ ĐŽŵƉĞƚŝƚŝǀĞ ƉƌŽĚƵĐƚƐ ĂŶĚ ƉƌŽĚƵĐƚ ĐĂŶĚŝĚĂƚĞƐ ͖ ĂŶĚ ƚŚĞ ƌŝƐŬ ĨĂĐƚŽƌƐ ĚŝƐĐƵƐƐĞĚ ƵŶĚĞƌ ƚŚĞ ŚĞĂĚŝŶŐ ͞ /ƚĞŵ ϭ ͘ ZŝƐŬ &ĂĐƚŽƌƐ ͟ ŝŶ ƚŚĞ ŽŵƉĂŶLJ ͛ Ɛ ĂŶŶƵĂů ƌĞƉŽƌƚ ŽŶ &Žƌŵ ϭϬ Ͳ < ĨŝůĞĚ ǁŝƚŚ ƚŚĞ h ͘ ^ ͘ ^ĞĐƵƌŝƚŝĞƐ ĂŶĚ džĐŚĂŶŐĞ ŽŵŵŝƐƐŝŽŶ ŽŶ DĂƌĐŚ ϯϭ ͕ ϮϬϮϱ ĂƐ ƵƉĚĂƚĞĚ ďLJ ĂŶLJ ƌŝƐŬ ĨĂĐƚŽƌƐ ĚŝƐĐůŽƐĞĚ ƵŶĚĞƌ ƚŚĞ ŚĞĂĚŝŶŐ ͞ /ƚĞŵ ϭ ͘ ZŝƐŬ &ĂĐƚŽƌƐ ͟ ŝŶ WĂƌƚ // ŽĨ ƚŚĞ ŽŵƉĂŶLJ ͛ Ɛ ƐƵďƐĞƋƵĞŶƚůLJ ĨŝůĞĚ ƋƵĂƌƚĞƌůLJ ƌĞƉŽƌƚƐ ŽŶ &Žƌŵ ϭϬ Ͳ Y ͘ dŚĞ ŽŵƉĂŶLJ ŽƉĞƌĂƚĞƐ ŝŶ Ă ǀĞƌLJ ĐŽŵƉĞƚŝƚŝǀĞ ĂŶĚ ƌĂƉŝĚůLJ ĐŚĂŶŐŝŶŐ ĞŶǀŝƌŽŶŵĞŶƚ ͘ EĞǁ ƌŝƐŬƐ ĞŵĞƌŐĞ ĨƌŽŵ ƚŝŵĞ ƚŽ ƚŝŵĞ ͘ 'ŝǀĞŶ ƚŚĞƐĞ ƌŝƐŬƐ ĂŶĚ ƵŶĐĞƌƚĂŝŶƚŝĞƐ͕ ƚŚĞ ŽŵƉĂŶLJ ĐĂƵƚŝŽŶƐ ĂŐĂŝŶƐƚ ƉůĂĐŝŶŐ ƵŶĚƵĞ ƌĞůŝĂŶĐĞ ŽŶ ƚŚĞƐĞ ĨŽƌǁĂƌĚ Ͳ ůŽŽŬŝŶŐ ƐƚĂƚĞŵĞŶƚƐ͕ ǁŚŝĐŚ ŽŶůLJ ƐƉĞĂŬ ĂƐ ŽĨ ƚŚĞ ĚĂƚĞ ŽĨ ƚŚŝƐ ƉƌĞƐĞŶƚĂƚŝŽŶ ͘ dŚĞ ŽŵƉĂŶLJ ĚŽĞƐ ŶŽƚ ƉůĂŶ ĂŶĚ ƵŶĚĞƌƚĂŬĞƐ ŶŽ ŽďůŝŐĂƚŝŽŶ ƚŽ ƵƉĚĂƚĞ ĂŶLJ ŽĨ ƚŚĞ ĨŽƌǁĂƌĚ Ͳ ůŽŽŬŝŶŐ ƐƚĂƚĞŵĞŶƚƐ ŵĂĚĞ ŚĞƌĞŝŶ͕ ĞdžĐĞƉƚ ĂƐ ƌĞƋƵŝƌĞĚ ďLJ ůĂǁ ͘ 2 ͮƵƐŝŶĞƐƐhƉĚĂƚĞEŽǀĞŵďĞƌ ϮϬϮϱ

 

 

s/DdŚĞƌĂƉLJ WƌŽŐƌĂŵŵĂďůĞ͕ƉĂĐĞŵĂŬĞƌ Ͳ ĚĞůŝǀĞƌĞĚ ƚƌĞĂƚŵĞŶƚĨŽƌŚŝŐŚďůŽŽĚƉƌĞƐƐƵƌĞĂŶĚ ŚLJƉĞƌƚĞŶƐŝǀĞŚĞĂƌƚĚŝƐĞĂƐĞ Virtue SAB Proprietary, non - coated sirolimus balloon angioplasty system for atherosclerotic artery disease and other indications Key Investment Highlights Leveraging Partnerships to Bring Innovation to Patients & Yield Exceptional Future Profitability Pivotal Stage, High - Impact Therapies >ĂƌŐĞ͕ƐƚĂďůŝƐŚĞĚ dĂƌŐĞƚDĂƌŬĞƚƐ ^ƚƌĂƚĞŐŝĐĐŽůůĂďŽƌĂƚŝŽŶ Partnership - Enabled Business Model &ƵŶĚĞĚdŚƌŽƵŐŚ <ĞLJDŝůĞƐƚŽŶĞƐ ϯ Strategic rights agreement Hypertensive Heart Disease : >$17B annual global opportunity Atherosclerotic Artery Disease : >$10B annual global opportunity Ψ ϯϭ͘ϲ ŵŝůůŝŽŶ ĐŽŵŵŝƚƚĞĚďLJ ŽƵďůĞ Ͳ ĚŝŐŝƚƌĞǀĞŶƵĞƐŚĂƌĞ Right of F irst Refusal in coronary market Ψ ϭϰϳ DнŝŶŶĞǁĐĂƉŝƚĂůƌĂŝƐĞĚƐŝŶĐĞƵŐƵƐƚ ϮϬϮϱ ͕ůĞĚďLJƐƚƌĂƚĞŐŝĐŝŶǀĞƐƚŵĞŶƚƐ͗ Ψ ϰϬ ŵŝůůŝŽŶ ĐŽŵŵŝƚƚĞĚďLJ BACKBEAT S tudy enrollment completion & primary results readout Expected c ash runway through key milestones into Q4 2027 including: Virtue Trial enrollment completion Ψ ϯϬ ŵŝůůŝŽŶ ĐŽŵŵŝƚƚĞĚďLJ ͮƵƐŝŶĞƐƐhƉĚĂƚĞEŽǀĞŵďĞƌ ϮϬϮϱ

 

 

Over $147M in Strategic - Driven Financing Secured Since August 2025 Ψ ϴϱ DŽĨ^ƚƌĂƚĞŐŝĐĂƉŝƚĂůŽŵŵŝƚŵĞŶƚƐнΨ ϲϮ͘ϲ DƋƵŝƚLJ&ŝŶĂŶĐŝŶŐ Æ džƉĞĐƚĞĚƚŽWƌŽǀŝĚĞZƵŶǁĂLJŝŶƚŽ Y ϰ ϮϬϮϳ Ψ ϯϱ ŵŝůůŝŽŶ ĐŽŵŵŝƚƚĞĚƚŽƉƵƌĐŚĂƐĞƌŽLJĂůƚLJ Ͳ ďĂƐĞĚƌĞǀĞŶƵĞ ŝŶƚĞƌĞƐƚ͖ƉůƵƐ Ψ ϱ ŵŝůůŝŽŶ ĞƋƵŝƚLJŝŶǀĞƐƚŵĞŶƚ $ 31.6 million additional strategic investment commitment brings total investment amount to $ 81.6 million Ligand’s long - term capital commitment is tied to commercial success and reflects Orchestra’s significant future royalty - based revenue opportunity Collaboration expansion provides potential development pathway for future AVIM - enabled leadless pacemaker integration ƐƚĂďůŝƐŚĞĚďŝŽƉŚĂƌŵĂŝŶǀĞƐƚŽƌ ǁŝƚŚƚŝĞƌĞĚƌŽLJĂůƚLJŝŶƚĞƌĞƐƚ ŝŶKƌĐŚĞƐƚƌĂ ͛ ƐĨƵƚƵƌĞs/DdŚĞƌĂƉLJĂŶĚsŝƌƚƵĞ^ ƌĞǀĞŶƵĞƐ 'ůŽďĂůŵĂƌŬĞƚůĞĂĚĞƌŝŶĐĂƌĚŝĂĐƉĂĐŝŶŐƚŚĞƌĂƉLJ ĂŶĚ ĞdžŝƐƚŝŶŐĐŽůůĂďŽƌĂƚŽƌĨŽƌs/DdŚĞƌĂƉLJƉƌŽŐƌĂŵ 4 Ψ ϯϬ ŵŝůůŝŽŶƚŽƚĂůƉĂLJŵĞŶƚƐ ĂƐƐŽĐŝĂƚĞĚǁŝƚŚŶĞǁƐƚƌĂƚĞŐŝĐƌŝŐŚƚƐĂŐƌĞĞŵĞŶƚƐ ͮƵƐŝŶĞƐƐhƉĚĂƚĞEŽǀĞŵďĞƌ ϮϬϮϱ

 

 

Orchestra developed Virtue SAB from concept stage, owns all related IP, conducted all prior studies, and retains all development and distribution rights in all indications Terumo is a global leader in interventional cardiology devices: >$2.4B in annual revenues 1 Terumo purchased ROFR for Virtue SAB transactions with respect to the global coronary market • Orchestra free to engage actively with all strategic parties and solicit proposals • Terumo has 30 days following notice of a third - party proposal acceptable to Orchestra to exercise ROFR • Expires 90 days after disclosure of primary endpoint data from the Virtue Trial $65M in total payments and investments received over time from Terumo • $10M paid in consideration of ROFR, plus $20M purchase of non - voting preferred with minimum $12/share conversion after Virtue Trial results announced • Initially paid $30M for Virtue SAB rights under original distribution agreement plus $5M equity investment Terumo ROFR Agreement Highlights Strategic Interest & Optionality ROFR = Right of First Refusal; 1 Based on Terumo’s consolidated financial results for the fiscal year ended March 31, 2025. ϱ | Business Update November 2025

 

 

sŝƌƚƵĞ Π ^KǀĞƌǀŝĞǁ ƌƵŐ Ͳ ĐŽĂƚĞĚďĂůůŽŽŶƐ;ͿĞŵĞƌŐŝŶŐĂƐŶĞǁƐƚĂŶĚĂƌĚŽĨĐĂƌĞ ĨŽƌŬĞLJĐŽƌŽŶĂƌLJĂŶĚ ƉĞƌŝƉŚĞƌĂůŝŶĚŝĐĂƚŝŽŶƐ ŽƐƚŽŶ^ĐŝĞŶƚŝĨŝĐ ͛ Ɛ'EdWĂĐůŝƚĂdžĞů Ͳ ĐŽĂƚĞĚďĂůůŽŽŶh^ĐŽŵŵĞƌĐŝĂůŝnjĂƚŝŽŶƵŶĚĞƌǁĂLJ ǁŝƚŚ ƉŽƐŝƚŝǀĞŝŶĚŝĐĂƚŝŽŶƐŽĨƐĂůĞƐŐƌŽǁƚŚ Paradigm Shift Unlocks High - Growth Opportunity in Large $10B Established Market 4 Virtue SAB is Designed to Redefine Arterial Drug Delivery with Significant Differentiation 1 Verheye et al. JACC Cardiovasc Interv 2017 Oct 23;10(20):2029 - 2037. DOI: 10.1016/j.jcin.2017.06.021. 2 Revised per protocol analysis set meets the criteria of the proposed In - Stent Restenosis IDE study population. 3 Granada 3 - Year Clinical Results TCT 2018. 4 Total addressable market in 2025 based on company estimates. WƌŽƉƌŝĞƚĂƌLJ^ŝƌŽůŝŵƵƐ&Z ĞdžƚĞŶĚƐƌĞůĞĂƐĞ ŽĨƚŚĞƌĂƉĞƵƚŝĐůĞǀĞůƐŽĨ ͞ ŐŽůĚ Ͳ ƐƚĂŶĚĂƌĚ ͟ ĚƌƵŐƚŚƌŽƵŐŚ ĐƌŝƚŝĐĂůŚĞĂůŝŶŐƉĞƌŝŽĚ EŽŶ Ͳ ĐŽĂƚĞĚ ŵŝĐƌŽƉŽƌŽƵƐďĂůůŽŽŶĚĞƐŝŐŶĞĚƚŽ ƉƌŽƚĞĐƚĚƌƵŐŝŶƚƌĂŶƐŝƚƚŽĐŽŶƐŝƐƚĞŶƚůLJĚĞůŝǀĞƌůĂƌŐĞůŝƋƵŝĚĚŽƐĞ ŽǀĞƌĐŽŵŝŶŐƚŚĞůŝŵŝƚĂƚŝŽŶƐŽĨĚƌƵŐ Ͳ ĐŽĂƚĞĚďĂůůŽŽŶƐ ĞƐƚ Ͳ ŝŶ Ͳ ĐůĂƐƐĐůŝŶŝĐĂůĚĂƚĂĨƌŽŵ^ZƉŝůŽƚƐƚƵĚLJ ƐŚŽǁƐƉƌŽŵŝƐŝŶŐĂŶĚĚƵƌĂďůĞƐĂĨĞƚLJĂŶĚĞĨĨŝĐĂĐLJŝŶ ĐŽƌŽŶĂƌLJ/^Z͕ǁŝƚŚ Ϯ͘ϴ йd>&Ăƚ ϭ LJĞĂƌĂŶĚ Ϭ йd>ZďĞƚǁĞĞŶ ϭ Ͳ ϯ LJĞĂƌƐ ϭ ͕Ϯ͕ϯ ϲ Recently Launched U.S. IDE Pivotal Study and Robust Reimbursement Landscape KƌĐŚĞƐƚƌĂŝŽDĞĚŝƐƐƉŽŶƐŽƌŝŶŐĂŶĚŝŶĨƵůůŽƉĞƌĂƚŝŽŶĂůĐŽŶƚƌŽůŽĨ sŝƌƚƵĞh^ĐŽƌŽŶĂƌLJ/ƚƌŝĂů ƌĂŶĚŽŵŝnjŝŶŐ ϭ͗ϭ ƚŽŽƐƚŽŶ^ĐŝĞŶƚŝĨŝĐΖƐ'EdW džƉĞĐƚĞĚĞŶŚĂŶĐĞĚƌĞŝŵďƵƌƐĞŵĞŶƚ ƐƵƉƉŽƌƚŝŶŐůĂƌŐĞĐŽŵŵĞƌĐŝĂůŽƉƉŽƌƚƵŶŝƚLJ ͮƵƐŝŶĞƐƐhƉĚĂƚĞEŽǀĞŵďĞƌ ϮϬϮϱ

 

 

Protected Delivery of Extended Release Sirolimus Virtue ® SAB – Optimal Drug, Dose and Delivery 1 Granada et al. EuroIntervention 2016;12:740 - 747. 2 Animals included in the analysis of distant organs received average dose of 20.4 mg ≈10X the largest clinical dose ^ŝƌŽůŝŵƵƐ&Z DŝĐƌŽƉŽƌŽƵƐŶŐŝŽ/ŶĨƵƐŝŽŶ ĂůůŽŽŶ Large Liquid Dose Loaded and Protected in Dose Unit Delivered Through the Micropores During Inflation NO coating = NO drug loss in transit, NO rush and NO large particulate ϭϬϬϬ ϭϬϬ 10 1 0.1 Ϭ͘Ϭϭ Ϭ͘ϬϬϭ 0.0001 Ϯ >ƵŶŐ͕ůŝǀĞƌΘŬŝĚŶĞLJďĞůŽǁůĞǀĞůŽĨĂƐƐĂLJ ƋƵĂŶƚŝĨŝĐĂƚŝŽŶ; Ϭ͘ϭ ŶŐͬŵŐͿŝŶф ϭ ǁĞĞŬ Ϭ 5 10 15 ϮϬ Ϯϱ 30 dĂƌŐĞƚ>ĞƐŝŽŶ ŝƐƚĂůDLJŽĐĂƌĚŝƵŵ <ŝĚŶĞLJ >ŝǀĞƌ >ƵŶŐ dŝŵĞ;ĂLJƐͿ N = 753 porcine coronary artery segments Sirolimus Tissue Concentration (ng/mg) Published Data Demonstrates Therapeutic Tissue Concentrations Through Critical Healing Period (~30 Days) 1 ZĞƋƵŝƌĞĚdŚĞƌĂƉĞƵƚŝĐŽŶĐĞŶƚƌĂƚŝŽŶх ϭ ŶŐͬŵŐ ϳ | Business Update November 2025

 

 

>Žǁ Ϯ͘ϴ йdĂƌŐĞƚ>ĞƐŝŽŶ&ĂŝůƵƌĞ ;d>&ͿĂƚ ϭ LJĞĂƌ >Žǁ Ϭ͘ϭϮ ŵŵ>ĂƚĞ>ƵŵĞŶ>ŽƐƐ ;>>>ͿĂƚ ϲ Ͳ ŵŽŶƚŚƐ 0% Target Lesion Revascularization (TLR) between 1 - 3 years Virtue® SAB demonstrated encouraging safety and efficacy results in patients with coronary in - stent restenosis (ISR) in prospective, multi - center SABRE Trial 1,2,3 Compelling SABRE Trial Results in Coronary ISR Patients sŝƌƚƵĞ^>ŽǁǀĞŶƚZĂƚĞƐKƵƚƚŽ ϯ zĞĂƌƐ ^ŝŶŐůĞ Ͳ >ĂLJĞƌZĞƐƚĞŶŽƐŝƐ 0% 5% 10% 15% 20% 25% ϱ͘ϲ й 2.8% Ϯ͘ϴ й Ϯ͘ϴ й 0% 0% 0% Ϭ й Ϭ й 0% Ϭ й Ϯ͘ϴ й Cardiac Death TV - MI TLR d>& ǀĞŶƚZĂƚĞƐ;йͿ 30 days 1 - year 3 - years ϭ sĞƌŚĞLJĞĞƚĂů͘:ĂƌĚŝŽǀĂƐĐ/ŶƚĞƌǀ ϮϬϭϳ KĐƚ Ϯϯ ͖ ϭϬ ; ϮϬ Ϳ͗ ϮϬϮϵ Ͳ ϮϬϯϳ ͘K/͗ ϭϬ͘ϭϬϭϲ ͬũ͘ũĐŝŶ͘ ϮϬϭϳ͘Ϭϲ͘ϬϮϭ ͘ Ϯ ZĞǀŝƐĞĚƉĞƌƉƌŽƚŽĐŽů ĂŶĂůLJƐŝƐƐĞƚŵĞĞƚƐƚŚĞĐƌŝƚĞƌŝĂŽĨƚŚĞƉƌŽƉŽƐĞĚ/Ŷ Ͳ ^ƚĞŶƚZĞƐƚĞŶŽƐŝƐ/ƐƚƵĚLJƉŽƉƵůĂƚŝŽŶ͘ ϯ 'ƌĂŶĂĚĂ ϯ Ͳ zĞĂƌůŝŶŝĐĂůZĞƐƵůƚƐdd ϮϬϭϴ ͘ ĞĨŝŶŝƚŝŽŶƐ͗ dĂƌŐĞƚůĞƐŝŽŶĨĂŝůƵƌĞ;d>&Ϳ͕ůĂƚĞůƵŵĞŶůŽƐƐ;>>>Ϳ͕ƚĂƌŐĞƚůĞƐŝŽŶƌĞǀĂƐĐƵůĂƌŝnjĂƚŝŽŶ;d>ZͿĂŶĚDLJŽĐĂƌĚŝĂů/ŶĨĂƌĐƚŝŽŶ;D/Ϳ͘ ϴ | Business Update November 2025

 

 

Target Lesion Failure 13.5% (AGENT) and 13.2% (SELUTION) (TLF) at 1 year No angiographic follow - up in both IDE AGENT LLL = 0.397mm at 6 months 4 ; SELUTION LLL not reported for coronary ISR 'EdΘ^>hd/KE ϰ /^Z/dƌŝĂůZĞƐƵůƚƐ^ŚŽǁůĞĂƌ KƉƉŽƌƚƵŶŝƚLJĨŽƌsŝƌƚƵĞ^ 0% 5% 10% 15% 20% 25% 20.2% ϭϯ͘ϱ й ϭ zĞĂƌ 2 Year Event Rates (%) AGENT POBA ;Ŷс ϯϰϭ Ϳ 'Edd>&KƵƚƚŽ Ϯ LJĞĂƌƐ Single - Layer Restenosis 1,2 ϭ zĞŚZt͕^ŚůŽĨŵŝƚnjZ͕DŽƐĞƐ:͕ĞƚĂů͘:D͘ ϮϬϮϰ ͖ ϯϯϭ ; ϭϮ Ϳ͗ ϭϬϭϱ ʹ ϭϬϮϰ ͘ĚŽŝ͗ ϭϬ͘ϭϬϬϭ ͬũĂŵĂ͘ ϮϬϮϰ͘ϭϯϲ ͘ Ϯ DŽƐĞƐ͕:dǁŽ Ͳ zĞĂƌ KƵƚĐŽŵĞƐĨƌŽŵƚŚĞ'Ed/dƌŝĂůZd ϮϬϮϱ ͘ ϯ ƵƚůŝƉ ĞƚĂů͘^>hd/KE ϰ /^ZůŝŶŝĐĂůdƌŝĂůdd ϮϬϮϱ ͘ ϰ ŽƐƚŽŶ^ĐŝĞŶƚŝĨŝĐ'Ed ƌŽĐŚƵƌĞ ϮϬϭϳ ͘ ĞĨŝŶŝƚŝŽŶƐ͗ WůĂŝŶŽůĚďĂůůŽŽŶĂŶŐŝŽƉůĂƐƚLJ;WKͿ͕^ƚĂŶĚĂƌĚŽĨĐĂƌĞ;^KͿ͕ůĂƚĞůƵŵĞŶůŽƐƐ;>>>Ϳ Ϯϲ͘ϲ й 20.7% AGENT 53% relative increase in TLF from 1 to 2 years 9 0% 5% 10% 15% 20% 25% ϭϯ͘Ϯ й ϭ zĞĂƌ Event Rates (%) ;Ŷс ϭϲϳ Ϳ ^>hd/KEd>&Ăƚ ϭ LJĞĂƌ Single - Layer Restenosis 3 SELUTION SOC 10.0% ^K Ε ϴϬ й^ ϮϬ йWK WK POBA ĚĂƉƚĞĚĨƌŽŵ Ϯ ƐĞƉĂƌĂƚĞ/dƌŝĂůƐ ͮƵƐŝŶĞƐƐhƉĚĂƚĞEŽǀĞŵďĞƌ ϮϬϮϱ

 

 

The Virtue Trial – U.S. Randomized Pivotal Coronary ISR Trial Designed to Secure Regulatory Approval & Showcase Differentiation of Virtue SAB R ϳϰϬ WƚƐǁŝƚŚ/^Z>ĞƐŝŽŶƐŝŶƌƚĞƌŝĞƐ Ϯ͘ϬϬ ʹ ϰ͘ϬϬ ŵŵ sŝƌƚƵĞ^ŝƌŽůŝŵƵƐ ŶŐŝŽ/ŶĨƵƐŝŽŶ ĂůůŽŽŶ 1:1 ϯϳϬ WƚƐ͘ ϯϳϬ WƚƐ͘ 12 M 12 M Clinical Follow - Up out to 5 Years WƌŝŵĂƌLJŶĚƉŽŝŶƚ͗ dĂƌŐĞƚ>ĞƐŝŽŶ&ĂŝůƵƌĞ;d>&ͿĂƚ ϭϮ ŵŽŶƚŚƐ WƌŝŵĂƌLJĂŶĂůLJƐŝƐŶŽŶ Ͳ ŝŶĨĞƌŝŽƌŝƚLJĐŽŵƉĂƌŝƐŽŶ ĚĚŝƚŝŽŶĂůƐƵƉĞƌŝŽƌŝƚLJƚĞƐƚƉĞƌĨŽƌŵĞĚƵƉŽŶĐŽŶĨŝƌŵŝŶŐŶŽŶ Ͳ ŝŶĨĞƌŝŽƌŝƚLJ 'Ed WĂĐůŝƚĂdžĞůŽĂƚĞĚ ĂůůŽŽŶ FDA IDE approved 1:1 RCT vs AGENT N=740 Up to 75 US Sites Primary endpoint 12 - Month TLF Planned initiation 2H 2025 ϭϬ ͮƵƐŝŶĞƐƐhƉĚĂƚĞEŽǀĞŵďĞƌ ϮϬϮϱ

 

 

AVIM Therapy Overview Hypertension is the leading global risk factor for death, affecting 1.2B patients Uncontrolled HTN in older, higher - risk patients drives MI, stroke and heart failure Reductions as small as 5 mmHg in office systolic bloo d pressure substantially decrease the relative risk of major cardiovascular events and conditions A Purpose - Built Solution for HTN Patients with Increased Risk in $17B Market WĂƚĞŶƚĞĚƚŚĞƌĂƉLJĚĞůŝǀĞƌĞĚĂƐ ĨŝƌŵǁĂƌĞĞŶŚĂŶĐĞŵĞŶƚƚŽƉĂĐĞŵĂŬĞƌ ĞƐŝŐŶĞĚƚŽĚƌŝǀĞ ŝŵŵĞĚŝĂƚĞ͕ƐƵďƐƚĂŶƚŝĂůĂŶĚƐƵƐƚĂŝŶĞĚďůŽŽĚƉƌĞƐƐƵƌĞƌĞĚƵĐƚŝŽŶ ZŽďƵƐƚďŽĚLJŽĨĐůŝŶŝĐĂůĂŶĚŵĞĐŚĂŶŝƐƚŝĐĚĂƚĂ /ŶŝƚŝĂůƚĂƌŐĞƚŝƐƉĂĐĞŵĂŬĞƌƉŽƉƵůĂƚŝŽŶ͕ǁŚĞƌĞ ,dEŝƐƚŚĞη ϭ ĐŽŵŽƌďŝĚŝƚLJ WŽƚĞŶƚŝĂůƚŽĞdžƉĂŶĚƚŽ ŵŝůůŝŽŶƐŽĨ,dEƉĂƚŝĞŶƚƐǁŝƚŚŝŶĐƌĞĂƐĞĚsƌŝƐŬ WŽƚĞŶƚŝĂůďĞŶĞĨŝƚŝŶ ,&Ɖ&ƉƌĞǀĞŶƚŝŽŶĂŶĚƚƌĞĂƚŵĞŶƚ FDA Breakthrough Designation for Beachhead Market and Beyond EŽǀĞů͕ WƌŽŐƌĂŵŵĂďůĞ͕ůǁĂLJƐ Ͳ KŶ dŚĞƌĂƉLJ ŽůůĂďŽƌĂƚŝŽŶ ǁŝƚŚ 11 | Business Update November 2025

 

 

The BACKBEAT Study – Global Pivotal Hypertension Trial ĞƐŝŐŶĞĚƚŽ^ĞĐƵƌĞZĞŐƵůĂƚŽƌLJƉƉƌŽǀĂůΘ^ŚŽǁĐĂƐĞEŽǀĞůƉƉƌŽĂĐŚƚŽůŽŽĚWƌĞƐƐƵƌĞDĂŶĂŐĞŵĞŶƚ WƌŝŵĂƌLJĨĨŝĐĂĐLJŶĚƉŽŝŶƚ͗ D ĞĂŶĐŚĂŶŐĞŝŶ Ϯϰ Ͳ ŚŽƵƌĂ^WĂƚ ϯ Ͳ ŵŽŶƚŚƐ WƌŝŵĂƌLJ^ĂĨĞƚLJŶĚƉŽŝŶƚ͗ &ƌĞĞĚŽŵĨƌŽŵƵŶĂŶƚŝĐŝƉĂƚĞĚƐĞƌŝŽƵƐĂĚǀĞƌƐĞĚĞǀŝĐĞĞǀĞŶƚƐĂƚ ϯ ŵŽŶƚŚƐ ĚĚŝƚŝŽŶĂů^ĞĐŽŶĚĂƌLJŶĚƉŽŝŶƚƐ͗ ĨĨŝĐĂĐLJĂŶĚƐĂĨĞƚLJĞŶĚƉŽŝŶƚƐĂĨƚĞƌ ϭϮ Ͳ ŵŽŶƚŚĨŽůůŽǁ Ͳ ƵƉ KƉƚŝŽŶƚŽĐƌŽƐƐŽǀĞƌƚŽ Ž ƉĞŶ Ͳ ůĂďĞů н Ϯϰ ŵŽŶƚŚƐƵŶďůŝŶĚĞĚĨŽůůŽǁ Ͳ ƵƉƉŚĂƐĞ Randomized, prospective, multi - center, double - blind, controlled trial N= 500; 130+ s ites in U.S. and EU Estimated completion of enrollment mid - 2026 W ĂƚŝĞŶƚƐƉƌĞǀŝŽƵƐůLJŝŵƉůĂŶƚĞĚǁŝƚŚŽƌ ŝŶĚŝĐĂƚĞĚĨŽƌ Ă DĞĚƚƌŽŶŝĐƐƚƌĂ ŽƌnjƵƌĞ ĚƵĂů Ͳ ĐŚĂŵďĞƌƉĂĐĞŵĂŬĞƌ ǁŚŽŚĂǀĞŚLJƉĞƌƚĞŶƐŝŽŶĚĞƐƉŝƚĞ ϭ Ͳ ϯ ĂŶƚŝ Ͳ ,dEŵĞĚŝĐĂƚŝŽŶƐ s/DdŚĞƌĂƉLJ ĚŽǁŶůŽĂĚΘƐĞƚƵƉ R AVIM Therapy + Medical Therapy Medical Therapy ϭϮ ͮƵƐŝŶĞƐƐhƉĚĂƚĞEŽǀĞŵďĞƌ ϮϬϮϱ

 

 

FDA Breakthrough Device Designation Highlights Potential For AVIM Therapy to Impact Hypertensive Heart Disease ΎĂƐĞĚŽŶĐŽŵƉĂŶLJĞƐƚŝŵĂƚĞƐ͘ WŽƉƵůĂƚŝŽŶŽĨƉĂĐĞŵĂŬĞƌ Ͳ ŝŶĚŝĐĂƚĞĚƉĂƚŝĞŶƚƐǁŝƚŚ ƵŶĐŽŶƚƌŽůůĞĚŚLJƉĞƌƚĞŶƐŝŽŶ ĚĞƐƉŝƚĞŵĞĚŝĐĂƚŝŽŶ ŐĞŶĞƌĂůůLJŵĞĞƚƐ& ďƌĞĂŬƚŚƌŽƵŐŚĐƌŝƚĞƌŝĂ HTN Despite Medication Increased 10 - year ASCVD R isk and Preserved LVEF 7.7M+ U.S. Patient Population That Fits FDA Breakthrough Designation Criteria* /ƐŽůĂƚĞĚ^LJƐƚŽůŝĐ ,LJƉĞƌƚĞŶƐŝŽŶͬ ŝĂƐƚŽůŝĐLJƐĨƵŶĐƚŝŽŶ Ϯ͘ϰ Dн Heart Failure with Preserved LVEF ϭ͘ϰ Dн ,dEΘ WĂĐĞŵĂŬĞƌ ~ 300K FDA BDD Announced April 22, 2025 13 ͮƵƐŝŶĞƐƐhƉĚĂƚĞEŽǀĞŵďĞƌ ϮϬϮϱ

 

 

&ĂǀŽƌĂďůĞ/ŵƉĂĐƚŽŶ,LJƉĞƌƚĞŶƐŝǀĞ,ĞĂƌƚŝƐĞĂƐĞ AVIM Therapy Clinical Results S how Potential to T reat ISH , Induce Reverse Remodeling, and Improve Diastolic Dysfunction ϭ ƵƌŬŚŽĨĨDKZdK//^ƚƵĚLJ Ϯ Ͳ zĞĂƌZĞƐƵůƚƐdd ϮϬϮϭ ͘ Ϯ sĂĐĐĂƌŝŶŽs͕ĞƚĂů͘ŵ: ĂƌĚŝŽů ͘ ϮϬϬϭ ϯ Eс ϭϰ s/DƚŚĞƌĂƉLJĂŶĚŶс ϭϭ ĐŽŶƚƌŽůŐƌŽƵƉ͘ ϰ &ƵĚŝŵD͕d,d ͛ Ϯϱ ͘ ĞĨŝŶŝƚŝŽŶƐ ͗ Ă^W;ĂŵďƵůĂƚŽƌLJ^LJƐƚŽůŝĐůŽŽĚWƌĞƐƐƵƌĞͿ͕Ž^W;KĨĨŝĐĞ^LJƐƚŽůŝĐůŽŽĚWƌĞƐƐƵƌĞͿ͕ >s;>ĞĨƚsĞŶƚƌŝĐƵůĂƌͿ͕Ws ;WƌĞƐƐƵƌĞsŽůƵŵĞͿ͕D;DŽŶƚŚƐͿ͘>s&;>ĞĨƚsĞŶƚƌŝĐƵůĂƌũĞĐƚŝŽŶ&ƌĂĐƚŝŽŶͿ͕Ez,;EĞǁzŽƌŬ,ĞĂƌƚƐƐŽĐŝĂƚŝŽŶͿ͕^W;^LJƐƚŽůŝĐů ŽŽĚ WƌĞƐƐƵƌĞͿ͘ :W ͗s/DdŚĞƌĂƉLJ/ŶĚƵĐĞĚZĞǀĞƌƐĞ ZĞŵŽĚĞůŝŶŐŝŶEŽŶŝŶǀĂƐŝǀĞWs>ŽŽƉ^ƚƵĚLJ ϭ͕ϯ JACC Advances: Improved Diastolic Dysfunction (DD) In Echocardiographic Analysis 4 AVIM Therapy Induced Reverse Remodeling Control Group Developed Ventricular Remodeling s/DƚŚĞƌĂƉLJ ƐŝŐŶŝĨŝĐĂŶƚůLJƌĞĚƵĐĞĚ^W ŝŶ ƉĂƚŝĞŶƚƐǁŝƚŚĂŶĚǁŝƚŚŽƵƚ s/DƚŚĞƌĂƉLJ ŝŵƉƌŽǀĞĚŵLJŽĐĂƌĚŝĂů ƌĞůĂdžĂƚŝŽŶĂŶĚŝŵƉƌŽǀĞĚĚŝĂƐƚŽůŝĐ ĐŽŵƉůŝĂŶĐĞ ;ƐŝŐŶŝĨŝĐĂŶƚůLJŝŶĐƌĞĂƐĞĚĞ ͛ ĂŶĚ ͬͿ ZĞƚƌŽƐƉĞĐƚŝǀĞ͕ƚƌĞĂƚŵĞŶƚ Ͳ ďůŝŶĚĞĚĂŶĂůLJƐŝƐŽĨĐŽƌĞůĂďĞĐŚŽĐĂƌĚŝŽŐƌĂŵƐ ĨƌŽŵDKZdK//͕ŚLJƉĞƌƚĞŶƐŝǀĞƉĂĐĞŵĂŬĞƌƉĂƚŝĞŶƚƐǁŝƚŚ>s& ш ϱϬ й ĂŶĚEz,ĐůĂƐƐф//͕ǁŝƚŚŝŶĚĞƉĞŶĚĞŶƚďůŝŶĚĞĚĂĚũƵĚŝĐĂƚŝŽŶ Significant Reduction in Challenging - To - Treat Isolated Systolic Hypertension (ISH) 1 о ϵ͘ϱ ŵŵ,Ő ŝŶ Ϯϰ Ͳ ,ŽƵƌĂ^W Ăƚ ϲ ŵŽŶƚŚƐ о ϭϱ͘ϴ ŵŵ,Ő ŝŶŽ^W Ăƚ Ϯ LJĞĂƌƐ − 9.6 mmHg ∆ in Ambulatory PP at 6 months − 13.9 mmHg ∆ in Office PP at 2 years >88% of AVIM Therapy patients in MODERATO II had ISH х ϲϭ йŽĨs/DdŚĞƌĂƉLJƉĂƚŝĞŶƚƐŝŶ DKZdK//ŚĂĚ /ŶĐƌĞĂƐĞĚ WƵůƐĞWƌĞƐƐƵƌĞ;WWͿĂŶŝŶĚĞƉĞŶĚĞŶƚƌŝƐŬ ĨĂĐƚŽƌĨŽƌŚĞĂƌƚĨĂŝůƵƌĞΘƐƚƌŽŬĞ Ϯ 14 ͮƵƐŝŶĞƐƐhƉĚĂƚĞEŽǀĞŵďĞƌ ϮϬϮϱ

 

 

s/DdŚĞƌĂƉLJĞŵŽŶƐƚƌĂƚĞƐ^ƵƐƚĂŝŶĞĚĂ^WZĞĚƵĐƚŝŽŶƐǁŝƚŚ ZĞƉƌŽĚƵĐŝďůĞĨĨĞĐƚĂŶĚEŽZĞďŽƵŶĚ,LJƉĞƌƚĞŶƐŝŽŶ 15 115 120 125 130 135 Baseline 6-Month Endpoint Day 0 Day 1 Day 7 Day 8 24 - Hr aSBP (mmHg) 122.8 ц 11.6 ϭϯϯ͘ϭ ц ϭϲ͘ϲ ϭϯϮ͘Ϯ ц ϭϯ͘ϰ 124.4 ц 10.1 Ɖс Ϭ͘ϬϬϭ Ɖс Ϭ͘ϬϬϮ 132.2 ц 7.0 122.8 ц 11.5 p < 0.001 DKZdK// s/DdŚĞƌĂƉLJK&& s/DdŚĞƌĂƉLJKE 16 MODERATO II patients with long - term follow - up & no increase in average number of meds had AVIM therapy de - activated & re - activated Immediate, substantial, and sustained reduction in aSBP seen across all study phases 1 Potential to halt hypertensive heart disease progression: aSBP returned to historical baseline after an average of 3.6 years 1 No rebound HTN observed during washout phase 1 t^,KhdΘZd/sd/KEW,^^ >KE' Ͳ dZD;s'͘ ϯ͘ϲ zZ^Ϳ No significant differences between measurements with AVIM Therapy ON (6 - month, day 0 and day 8) No significant differences between measurements with AVIM Therapy OFF (baseline, day 1 and day 7) 1 Kalarus et al., Time Course of Changes in Blood Pressure Upon Cessation of Chronic Atrioventricular Interval Modulation (AVIM ) Therapy, HRX 2025 abstract. Definition: aSBP (Ambulatory Systolic Blood Pressure), HTN (Hypertension), AVG (Average). n=16 ͮƵƐŝŶĞƐƐhƉĚĂƚĞEŽǀĞŵďĞƌ ϮϬϮϱ

 

 

WŝǀŽƚĂů^ƚĂŐĞ͕,ŝŐŚ Ͳ /ŵƉĂĐƚdŚĞƌĂƉŝĞƐ Large, Established Target Markets WĂƌƚŶĞƌƐŚŝƉ Ͳ ŶĂďůĞĚƵƐŝŶĞƐƐDŽĚĞů džƉĞĐƚĞĚ&ƵŶĚŝŶŐŝŶƚŽY ϰϮϬϮϳ 16 Key Investment Highlights Leveraging Partnerships to Bring Innovation to Patients & Yield Exceptional Future Profitability | Business Update November 2025

 

 

ƌŝŶŐŝŶŐ DĞĚŝĐĂů /ŶŶŽǀĂƚŝŽŶƐ ƚŽ >ŝĨĞ dŚƌŽƵŐŚ WĂƌƚŶĞƌƐŚŝƉƐ