Adona Medical Secures $33.5M Series C Funding to Advance Adjustable Atrial Shunt for Heart Failure

Jul 16, 2024 11:00 CST Updated 11:00

Adona Medical

Developer of Interventional Devices for Heart Failure

Source: Heart Future; Editor: Sophia

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Heart Future

Recently, Shifamed invested inAdona MedicalAnnounced inRaised $33.5 Million (RMB 240 Million) in Series C Financing，Support continued R&D of its coreAdjustable Cardiac Shunt Technology Products, is expected to also integrate dual atrial pressure monitoring functionality.Adjustable Atrial Shunt DevicePut into clinical use。

Cormorant Asset Management and TCP Health Ventures led this round of financing.。Excelstar Ventures, PA MedTech VC Fund II, Unorthodox Ventures, AMED Ventures, and other new and existing investors participated.

# Research and Development Background

Despite significant advances in medical and device therapies over the past few decades,But the incidence and mortality of left heart failure remain high.. In patients with chronic heart failure,Elevated left atrial pressure leads to pulmonary congestionIs a common mechanism leading to symptom exacerbation and acute decompensation.Atrial shunt can achieve shunt decompression, alleviate excessive left atrial volume, and improve symptoms caused by heart failure., improve the quality of life for patients, is an emerging minimally invasive interventional treatment.

Currently, devices used for atrial shunt procedures are mainly divided into two types:One is an atrial shunt with an implant, and the other is an atrial shunt without an implant.

The diameters of the atrial septal openings created by the two technologies are both fixed.Cannot be adjusted based on the patient's physical condition, so both atrial shunts have shortcomings:

Hemodynamic Mismatch:A fixed shunt aperture may not meet the hemodynamic needs of all patients, leading to...

Some patients are under-triaged, while others are over-triaged.

Increase Cardiac Burden:If the shunt aperture is too large, it may increase the load on the right atrium, leading to impaired right heart function, and potentially causing right heart failure in the long term.

Limited Improvement in Cardiac Function:For those who need moreFor patients with blood flow diversion to improve symptoms, a fixed small aperture may not provide sufficient hemodynamic improvement.

Therefore, the atrial shunt deviceThe design needs to take into account the individual differences of patients and the flexibility of treatment to achieve the best therapeutic effect with minimal risk.

SomeNovel Atrial ShuntIn progressAttempts to overcome these limitations through innovative designs, such as devices with adjustable shunt apertures or shunt technologies without implants,For example, Adona Medical,The company has developed aPostoperative Atrial Shunt with Flow Regulation Function。

Adona Medical's atrial shunt, Adona, compared to traditional atrial shunts such as IASD, V-Wave Ventura Shunt, and Alleviant System,The biggest difference lies in the postoperative flow adjustability.Allowing doctors to adjust the opening size of the Adona atrial shunt based on monitored changes in left and right atrial pressure,Thereby achieving for heart failure patientsPersonalized Treatment, rather than the traditional "one-size-fits-all" treatment approach of conventional shunts, ultimately avoiding various complications caused by the shunt being either too large or too small.

# Adona Atrial Shunt

Adona Atrial ShuntWith flow regulation functionAbility, Real-time Pressure Monitoring Function, which can help doctors determine whether the patient's stoma is too large or too small.

If the pressure deviates, the doctor can promptly adjust the stoma size through an interventional procedure to bring the pressure back to normal.

Biventricular Pressure Sensor:

Can monitor the pressure in the left and right atria,Monitor at least 5 times a day；

Adjustable shunt lumen:

The channel size after implantation is adjusted as needed.（EnlargementOr reduce);

The channel can be adjusted to a normal size of 5-10mm;

The channel can be temporarily expanded to more than 14mm, facilitating the conduction of transcatheter interventions from the femoral vein to the left heart (e.g., atrial fibrillation ablation, TMMR, etc.);

Packaged Anchor Bolt:Using biocompatibilityePTFE Materials Accelerate Healthy Tissue Response.

Principle of Adjustable Flow

Adona's internal stent adoptsPreparation of Nickel-Titanium Alloy, Nickel-titanium alloy isA shape memory alloy that can adjust its form at different temperatures.

Utilizing the shape memory properties of nickel-titanium alloy,When a larger channel is needed, it can be used.Balloon CatheterExpand，It even allows interventional catheters to enter the left heart from the right heart for ablation or other treatments.

When the directional flow is too large,When narrowing the channel is required, the innovative catheter developed by Adona Medical, the Adona Magnetic Catheter, can be utilized.This electromagnetic catheter can non-contact heat a portion of the implant in less than five seconds.And NitinolSuperelasticityMaking the heart valveSuch medical devices can be compressed in the catheter and return to their original shape after delivery.

# Quick Overview of Competing Products at Home and Abroad

Corvia Atrial Shunt – United StatesCorvia Medical

The World's FirstUsed for treatmentHeart Failure with Preserved Ejection Fraction (The atrial septal shunt device for HFpEF patients is manufactured byThe nitinol memory alloy cutting stent is composed of left and right atrial discs forming an internal clasp structure.

ObtainCE Certification、FDA Granted ItsBreakthrough Medical Device"Recognition Title."

The Second GenerationVenturaAtrial Shunt Device——IsraelV-Wave Company

Composed of an hourglass-shaped nitinol frame, with a polytetrafluoroethylene polymer coating on the left side and three bovine pericardial leaflets on the right.To prevent embolism and early shunt closure, which can be implanted via the femoral vein approach under transesophageal echocardiography guidance. Clinical testing began in a broader heart failure population in 2023.

Obtain ObtainCE Certification, FDA granted itsBreakthrough Medical DeviceRecognition Title.

AFR Atrial Shunt —— GermanyOcclutech Company

A nitinol mesh device consisting of two flat disks and a connecting neck with a central window.Blood from the heart can flow from the left side to the right side through its central shunt hole., to reduce the burden on the left atrium.

When AFR is implanted in the human body, it will maintain aFixed-Diameter Atrial ShuntMeanwhile, to meet the atrial shunting needs of different patients, the AFR offers four different fenestration diameters.

ObtainCE Certification, FDA granted itsBreakthrough Medical Device"Recognition Title."

Adona Medical

Developed by Adona MedicalNoYA Atrial Shunt System, isThe World's FirstSelf-developedNon-implantable, Adjustable Atrial Shunt Device。

The operator fixes the adjustable-diameter stent on the atrial septum, utilizing radiofrequency energy to heat, coagulate, and contract the surrounding atrial septal tissue, creating a permanent atrial septal opening.Adopting a design with an adjustable shunt orifice diameter, the stent can be adjusted in diameter from 4 to 10 mm, meeting various shunt requirements.

December 8, 2021Day,The Center for Medical Device Review of the National Medical Products Administration agrees with Adona Medical“Adjustable Interatrial Shunt System”Enter the special review process for innovative medical devices.

Adona Medical

D-Shant Atrial Shunt isChina's First Self-Developed Implantable Atrial Shunt Device。The ProductThe structural design adopts an internally embedded metal stent, which is only the size of a coin and provides excellent radial support.

At the same time, D-Shant can achieve secondary intervention to ensure surgical safety.

November 2023,Adona MedicalD-shant^®Atrial ShuntThe product has received the "Breakthrough Device Designation" from the U.S. FDA.

In addition,MicroPort CardioFlow, Qichen Medical Group, Aoliu MedicalThe atrial shunt devices of companies such as Adona Medical, Inc. have also entered the FIM study phase.

Currently, LePu Medical has under development the first, second, and third generations of atrial shunt devices, which are used to create left-to-right atrial shunts to effectively relieve left atrial load and improve heart failure symptoms and prognosis.

Features of Generation Ⅰ ProductsEffective radial support to maintain shunting. Dual-disc design ensures secure clamping.

Features of Generation Ⅱ ProductsBiodegradableMaterials, implant with no residue.

Characteristics of the Ⅲ Generation ProductsIt is the ablation of the atrial septum with radiofrequency energy, leaving no implants in the body.

In addition to innovations in adjustable diameter and retrievability, domestic companies have also made improvements in the size, endothelialization, and shape of atrial shunt devices.

# AboutAdona medical

Adona Medical was founded in 2017.Is a privately held company invested by Shifamed, LLC, and also a medical technology company in the preclinical stage.It isDevelopment of Next-Generation Atrial Shunt and Remote Patient Monitoring Solutions for Patients with Advanced Heart Failure。

Financing History:

In December 2019, Adona Medical announced the completion of its seed funding round.Total Amount Raised: $2.5 Million. The round of financing, raised solely by angel investors recognized by Shifamed, will be used to advance product development and expand the company's intellectual property portfolio.
In addition, Shifamed announced the appointment of seasoned medical device executive Brian Fahey as the CEO of Adona Medical.
In September 2020, Adona Medical completed$22 Million Series A Financing, which will be used to advance product development, support preclinical testing, and expand the team size. The company is further advancing its next-generation heart failure management platform.
This financing was led by Cormorant Asset Management, with participation from Excelestar Ventures, AMED Ventures, and select angel investors, including previous debt investments that were converted into preferred shares.
In May 2022, the companyRaised $37.5 Million in Series B Financing, which will be used to complete product development and support further evaluation of the company's next-generation heart failure management platform.
The financing was led by Cormorant Asset Management and The Capital Partnership (TCP), with participation from Excelestar Ventures, AMED Ventures, PA MedTech VC Fund, and Shifamed angel investors.

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