Blog of Intellectual Capital

Sale of Assets and Intellectual Property of Aria CV, Inc

Gerbsman Partners has been retained by Aria CV, Inc (“Aria”) to solicit interest in the acquisition of all, or substantially all, of the company’s assets, including its intellectual property, clinical data, device technology, and development infrastructure.  Please see attached Exhibit A, Aria CV NDA; Exhibit B, Aria CV Patent Status detail; Exhibit C, Aria CV Trademark detail; Exhibit D, Aria VC Fixed Asset List 12/31/25 and Sales Letter.

Based in St. Paul, Minnesota, Aria CV was founded in 2010 by Drs. John Scandurra and Karl Vollmers, who were members of a team that invented a novel implantable medical device designed to treat right heart failure due to Pulmonary Hypertension (PH) (“the technology”) during a fellowship at the University of Minnesota’s Earl E. Bakken Medical Devices Center. Independent market analyses estimate that this represents a multi-billion-dollar market opportunity.  Since then, the Aria system has been evaluated in 38 human implants across multiple clinical studies.

Aria has raised four rounds of private financing totaling $66 million from venture funds, family offices, and three large U.S.-based medical device companies that participated as strategic investors. The company holds 54 issued patents and four pending patent applications.

Strategic Rationale

Acquisition of Aria provides access to a clinically validated cardiovascular device platform targeting right ventricular dysfunction—an area of growing clinical importance with limited therapeutic options.

The technology may complement existing cardiovascular portfolios relating to PH, left heart failure, mechanical circulatory support (MCS), ADHF, and tricuspid valve interventions—while also creating opportunities for expansion into additional cardiovascular indications.

IMPORTANT LEGAL NOTICE:

The information in this memorandum does not constitute the whole or any part of an offer or a contract.

The information contained in this memorandum relating to Aria (defined below) has been supplied by Aria.  It has not been independently investigated or verified by Gerbsman Partners or its agents.

Potential purchasers should not rely on any information contained in this memorandum or provided by Aria, or Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.

Aria, Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of Aria’s or Gerbsman Partners’ negligence or otherwise. 

Any sale of the Aria Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of Aria or Gerbsman Partners.  Without limiting the generality of the foregoing, Aria and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the Aria Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

This memorandum contains confidential information and is not to be supplied to any person without Aria’s or Gerbsman Partners’ prior consent.  This memorandum and the information contained herein are subject to the non-disclosure agreement attached hereto as Exhibit A.

Aria CV Company Overview

Aria CV, Inc. is a privately held cardiovascular medical device company focused on developing novel therapies to improve right ventricular (RV) function by reducing right ventricular afterload. The company was founded in 2010 and is headquartered in St. Paul, Minnesota, one of the world’s leading centers of cardiovascular device innovation.

Since its founding, Aria has raised approximately $66 million in equity financing from a syndicate of institutional investors, strategic investors, and family offices. These funds have supported device engineering, extensive preclinical validation, regulatory engagement with the U.S. Food and Drug Administration, and multiple human clinical studies.

The Aria platform originated from work at the University of Minnesota Medical Devices Center, a globally recognized institution for cardiovascular device innovation. Over the past decade the company has advanced the technology through iterative design development, sophisticated hemodynamic modeling, extensive bench and durability testing, and both preclinical and human clinical evaluation.

The company has established the infrastructure required to support development of Class III implantable medical devices, including quality systems, design control processes, regulatory documentation, and clinical study management. These systems position the platform for continued development through pivotal clinical trials and eventual regulatory approval.

To date, the Aria system has been evaluated in 38 human implants across multiple studies including acute and chronic device configurations. Five patients remain chronically implanted and under active clinical follow-up, the first of whom was implanted over 2 years ago. The technology has received FDA Breakthrough Device Designation and has been studied under the Early Feasibility Study (EFS) program. The EFS Study ASPIRE-PH is approved and active but not enrolling at this time. 

Key Value Drivers

Aria believes its assets are attractive for several reasons:

·                     First‑in‑class cardiovascular device platform designed to mechanically reduce right ventricular afterload

·                     Human clinical validation with 38 human implants across multiple clinical studies and disease states

·                     FDA Breakthrough Device Designation reflecting potential to address a serious unmet clinical need

·                     Early Feasibility Study experience providing clinical proof‑of‑concept

·                     Large addressable markets including pulmonary hypertension and acute decompensated heart failure

·                     Substantial intellectual property portfolio covering multiple aspects of the technology

·                     Platform technology with potential expansion opportunities across additional cardiovascular indications

·                     Established development infrastructure including regulatory, clinical, and manufacturing documentation

Aria’s Assets

Aria has developed a portfolio of assets critical to reducing RV afterload and improving RV function. These assets fall into a variety of categories, including:

·                     54 issued patents, 4 pending patents and 2 trademarks in the U.S. and OUS

·                     Unique and clinically relevant prospective patient data set for treating RV dysfunction, PH and ADHF 

·                     Surgical and percutaneous technology and product Inventory

·                     Validated access devices and procedure

·                     Next generation product designs

·                     Manufacturing, design and supply chain

·                     Current FDA approved clinical trial (ASPIRE-PH, NCT04555161)

·                     Intellectual capital and expertise

Development, Quality and Regulatory Assets

In addition to the company’s patent portfolio, Aria has developed a substantial body of proprietary engineering, clinical, and regulatory documentation supporting the platform. These assets significantly reduce the time and cost required for a strategic acquirer to continue development.

·                     Key development assets include:

·                     Design History File (DHF) and engineering documentation

·                     Device Master Record (DMR) and product specifications

·                     Proprietary device design files, CAD models, and engineering drawings

·                     Validated bench testing and durability data

·                     Manufacturing processes and supply chain documentation

·                     Clinical study protocols, datasets, and regulatory submissions

·                     FDA correspondence and regulatory strategy documentation

·                     Validated implant procedures and access techniques

How Did We Get Here?

Enrollment in the Early Feasibility Study progressed more slowly than anticipated given the advanced disease state of many enrolled patients, requiring additional capital to continue clinical development. As a result of these capital constraints, the company initiated a strategic review process to identify an acquirer or partner capable of advancing the platform through late-stage clinical development and commercialization, or acquiring the company’s assets. 

Clinical Problem – Right Ventricular Dysfunction

Right ventricular dysfunction is increasingly recognized as a critical determinant of outcomes in multiple cardiovascular diseases including pulmonary hypertension, chronic heart failure, and acute decompensated heart failure.

In these conditions, structural changes within the pulmonary vasculature increase stiffness and reduce vascular compliance. As a result, the right ventricle must generate higher pressure to maintain pulmonary blood flow. Over time, this increased workload leads to progressive right ventricular dilation, reduced contractility, declining cardiac output, and eventual right heart failure.

The presence of right ventricular dysfunction is strongly associated with increased mortality, higher hospitalization rates, and diminished functional capacity. Despite its central role in disease progression, existing therapies largely focus on pharmacologic vasodilation or symptom management and do not directly address the mechanical drivers of RV afterload.

The Aria platform is designed specifically to address this hemodynamic problem by restoring pulmonary arterial compliance and directly reducing right ventricular workload.

Platform Highlights

·                     38 human implants

·                     7+ cumulative patient-years of chronic support

·                     FDA Breakthrough Device Designation

·                     61m improvement in 6MWD

·                     54 issued patents

·                     Two active clinical trials

Technology Overview

The Aria system is an implantable device placed within the pulmonary artery that functions to restore pulmonary vascular compliance and reduce right ventricular afterload.  The device is passive and does not require external power, controls, or synchronization systems. It is driven entirely by the beating heart and automatically synchronizes with the cardiac cycle.

The device incorporates a gas‑filled balloon connected to a reservoir system. During systole, as blood is ejected from the right ventricle into the pulmonary artery, the balloon compresses and absorbs pulsatile energy. This action reduces peak pulmonary artery pressure and lowers right ventricular workload.

During diastole, the balloon expands and returns stored energy to the circulation, helping maintain forward pulmonary blood flow. This dynamic interaction effectively restores more physiologic pressure‑flow relationships within the pulmonary circulation.

The result is reduced right ventricular workload, improved ventricular efficiency, and potential improvements in cardiac output and systemic perfusion.

Clinical Experience

Clinical Highlights

·                     Two approved clinical trials

·                     38 human implants across acute and permanent device configurations

·                     7+ cumulative patient-years of chronic device support

·                     Five patients currently implanted with long-term devices

·                     Immediate reduction in right ventricular afterload observed in acute studies

·                     Improved cardiac output and pulmonary artery compliance

·                     Improved six-minute walk distance (6MWD) and functional capacity

·                     Improved echocardiographic measures of right ventricular function

·                     FDA Breakthrough Device Designation

Clinical Results and Patient Outcomes

The Aria platform has been evaluated in multiple human clinical studies designed to assess device safety, hemodynamic performance, and potential clinical benefit.

Across these studies, investigators have observed consistent improvements in right ventricular hemodynamics and patient functional status, supporting the therapeutic potential of the technology.

Acute First-in-Human Study

The first clinical evaluation of the Aria system was conducted in patients with advanced pulmonary hypertension and right ventricular dysfunction in Vienna, Austria. This study included 28 acute implants across multiple pulmonary hypertension etiologies.

Key findings included:

·                     Immediate reduction in right ventricular afterload

·                     Improved pulmonary artery compliance

·                     Increased cardiac output

·                     Improved right ventricular–left ventricular interaction, including reductions in left atrial pressure

·                     No device-related or procedure-related complications

These results provided the first clinical validation that mechanical modulation of pulmonary artery compliance could directly improve right ventricular hemodynamics.

U.S. Early Feasibility Study (ASPIRE-PH) – Permanent Implant

Building on the initial human experience, Aria initiated the ASPIRE-PH Early Feasibility Study in the United States to evaluate the permanent implant configuration under FDA’s Breakthrough Device Designation.

·                     The first nine permanent implants demonstrated:

·                     Durable device function

·                     Sustained improvements in hemodynamics

·                     Successful implantation and procedural feasibility

·                     Long-term patient support with chronic implantation

·                     Five patients currently implanted and under long-term follow-up

Improvements in Right Ventricular Function

Device activation resulted in improved right ventricular function.

·                     Consistent and significant increases in Tricuspid Annular Plane Systolic Excursion (TAPSE) and Fractional Area Change (FAC), established echocardiographic markers of RV performance and prognosis

Improvements in Functional Capacity

In addition to hemodynamic improvements, investigators observed meaningful improvements in patient functional capacity.

Clinical observations across studies have included:

·                     Increased six-minute walk distance (6MWD) of 61 meters, approximately two times the threshold typically considered clinically meaningful in pulmonary hypertension studies.

·                     Improved exercise tolerance

·                     Improved patient-reported quality of life in two validated surveys

·                     Improved echocardiographic measures of right ventricular function (TAPSE and FAC)

These findings suggest that mechanical reduction of right ventricular afterload translates into meaningful functional benefits for patients.

Reduction in Pharmacologic Burden

Pulmonary hypertension patients frequently require complex multidrug therapy including prostacyclins, endothelin receptor antagonists, and PDE-5 inhibitors.

Clinical investigators have reported that improvements in right ventricular hemodynamics associated with the Aria device may allow for:

·                     Stabilization of disease progression

·                     Potential reduction in pharmacologic therapy burden

·                     Improved tolerance of medical therapy

While additional clinical studies will further define these effects, early clinical experience suggests that mechanical RV unloading complements existing pharmacologic treatments.

Short-Term Application in Acute Heart Failure

The Aria platform is also being evaluated in a short-term configuration for acute decompensated heart failure patients experiencing right ventricular dysfunction.  This approved OUS study has successfully treated one patient with severe left heart failure, RV dysfunction and diuretic resistance.

Early clinical experience suggests:

·                     Improved hemodynamics

·                     Improved exercise tolerance

·                     Favorable safety profile

This configuration is designed to provide temporary right ventricular unloading during acute hospitalization.  Improvements in right ventricular function, tricuspid regurgitation, and diuresis are anticipated.  Due to financial constraints, this promising area of investigation—using the Aria device to provide short-term (3–5 day) therapy for acute heart failure patients—was not pursued further despite the device being fully ready for clinical deployment in this indication.

Clinical Results Summary 

The Aria platform has been evaluated in multiple human studies including acute and chronic device configurations. These studies have provided important insights into device performance, safety, and potential clinical benefits.

Across these studies, investigators have observed favorable hemodynamic effects including reductions in RV afterload and improvements in cardiac output.

Clinical experience includes 38 human implants across both acute and permanent device configurations, with more than seven cumulative patient‑years of chronic device support.

In addition to hemodynamic improvements, investigators have observed encouraging trends in functional capacity and patient quality‑of‑life metrics.

Multibillion Dollar Market Opportunity

The Aria platform targets large and growing cardiovascular markets including pulmonary hypertension and acute decompensated heart failure.

Pulmonary hypertension affects a substantial global patient population and represents a multi‑billion‑dollar therapeutic market. Many patients with pulmonary hypertension ultimately develop right ventricular dysfunction, creating a large potential addressable population for the Aria device.  A conservative protocol-eligible estimate based on the ASPIRE-PH study population suggests a potential addressable market of approximately $4.6 billion for the permanent implant configuration.

Acute decompensated heart failure accounts for more than one million hospitalizations annually in the United States alone. A significant subset of these patients develop right ventricular dysfunction contributing to poor outcomes and prolonged hospital stays.  A conservative protocol-eligible market estimate for the short-term device (ARISE-HF study) supports a total addressable revenue of approximately $3 billion per year.

The ability to address both chronic and acute manifestations of right ventricular dysfunction creates a broad commercial opportunity for the platform.

Regulatory Status 

Aria has two currently approved clinical trials:

·                     ASPIRE-PH – U.S. EFS Study approved for up to 30 patients with Groups 1, 2 or 3 PH.  Under FDA’s Breakthrough Device Designation.  Currently not enrolling.

·                     ARISE-HF – OUS Study in Eastern Europe in patients with left heart failure consistent with ADHF.  Currently not enrolling.  

The Aria device has received FDA Breakthrough Device Designation, recognizing its potential to address a serious and life‑threatening condition with limited treatment options.

The technology has been evaluated under the FDA Early Feasibility Study program and has benefited from ongoing regulatory interaction with the Agency.

The pathway toward a pivotal clinical trial supporting Premarket Approval (PMA) has been defined.

Intellectual Property

The Aria platform is supported by 54 issued and 4 pending patents designed to protect the company’s core technology and future product evolution.

The portfolio includes multiple patent families covering pulmonary artery compliance modulation, implant design, delivery systems, and related technologies.

These patents provide broad protection for the platform and support long‑term commercial development.

Fixed Assets Summary

Aria CV – Intellectual Property Portfolio Summary

The following summary provides a high-level overview of the intellectual property estate supporting the Aria RV Afterload Reduction platform:

·                     Total Patent Families: 6

·                     Issued U.S. Patents: 23

·                     Issued OUS Patents: 31

·                     Pending Applications: 4

·                     Earliest Priority Date: 2010

·                     Latest Priority Date: 2020

·                     Claims cover pulmonary artery compliance modulation, implant architecture, gas retention, delivery systems, and short-term embodiments.

·                     All known inventor assignments executed, recorded and on file with Chris Bolten at Greenberg Traurig, LLP.

·                     Maintenance fees current as of Feb 27th

·                     Maintenance fees expected in 2026: $58,000

·                     Family 1: Filed 2010 and licensed from the University of Minnesota. Covers the original concept of reducing RV load in the presence of pulmonary hypertension.

·                     Family 2: Filed Late 2010, Covers the concept of a remote reservoir and conduit connecting balloon in a vessel to reduce Pulse Pressure in a vessel.

·                     Family 3: Filed 2014, Peripheral and enabling technology related to the device.

·                     Family 4: Filed 2016, Covers the use of composite polymer intended to utilize the unique diffusion barrier properties of Graphene in the device. 

·                     Family 5: Filed 2019, Covers the use of slowly diffusing gas to maintain the balloon gas volume for extended periods of time.   This technology extended the gas volume adjustment times from weeks to months. 

·                     Family 6: Filed 2020, Captures current device details.

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a nondisclosure agreement (attached hereto as Exhibit A) to have access to key members of the management and intellectual capital teams and the due diligence “war room” documentation (the “Due Diligence Access”).  Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has an opportunity to inspect and examine the Aria Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of Aria, Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and neither Aria nor Gerbsman Partners (or their respective, staff, agents, or attorneys) makes any representations as to the accuracy or completeness of the same.

Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the Aria Assets.  Sealed bids must be submitted so that the bid is actually received by Gerbsman Partners no later than Friday April 10, 2026, at 3:00 p.m. Eastern Standard Time (the “Bid Deadline”).  Please email steve@gerbsmanpartners.com with any bid.

Bids should be for all or substantially all of the assets of Aria, and if less than all, should identify those assets being tendered for in a specific and identifiable way.  The attached Aria fixed asset list may not be complete, and Bidders interested in the Aria Assets must submit a separate bid for such assets.  If bidding for less than all of the assets, bids should be specific as to the assets desired.

Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase where applicable.  All bids must be accompanied by a refundable deposit check in the amount of $200,000 (payable to Aria CV, Inc.). The winning bidder will be notified within 3 business days after the Bid Deadline.  Non-successful bidders will have their deposit returned to them.

Aria reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale.  Interested parties should understand that it is expected that the highest bid will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.

Aria will require the successful bidder to close within 7 business days.  Any or all of the assets of Aria will be sold on an “as is, where is” basis, with no representation or warranties whatsoever. 

All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the Aria Assets shall be the sole responsibility of the successful bidder and shall be paid to Aria at the closing of each transaction.

Contact Information

For additional information, please see below and/or contact:

Steven R. Gerbsman                                                                                                              

steve@gerbsmanpartners.com