Instylla Appoints Former BD Executive Sean Boyle as CEO Ahead of Commercial Launch

August 5, 2025, an innovative company focusing on absorbable peripheral vascular embolization solutions Instylla Announces Appointment of Former BD Medical Executive Sean Boyle For the company's new Chief Executive Officer (CEO)。Company founder Dr. Amar Sawhney will transition to the role of Chairman of the Board, continuing to lead the company's technology strategy and product direction.

This personnel change is not a "power transition" in the traditional sense, but a deep adjustment based on the stage of development, organizational structure, and execution capabilities. With the company's first product, the Tembo™ Embolization System, receiving FDA approval, and the next-generation flagship platform, the Embrace™ Gel Embolization System, completing its PMA submission, Instylla has officially entered the eve of commercialization. The addition of Sean Boyle marks that this "technology-intensive" enterprise is making the leap to becoming an "execution-driven" company.

# From Founder System to Executive System: A Well-Prepared Transition

Instylla, Inc. was founded in 2017, focusing on the development of bioabsorbable particle and liquid embolic platforms, dedicated to providing a new generation of minimally invasive treatment solutions for highly vascularized tumors, bleeding control, and other complex lesions. Over the past seven years, under the leadership of Amar Sawhney, the company has completed a series of early key tasks, including product validation, registration progress, clinical trials, and financing expansion.

Now, with the approval of the first product and the registration pipeline nearing commercial endpoint, the company has entered a dual-task phase of "product realization + market launch." For an enterprise at the juncture of clinical and commercial operations, the organizational logic must also evolve—shifting from a technology-driven culture to a market-oriented structure centered on execution efficiency.

Dr. Sawhney has chosen to "step back from the front line" this time, retaining his position as Chairman of the Board to focus on technical strategy and long-term planning, while handing over the CEO role to a professional manager with global business operation experience. This reflects a precise judgment on the company's development pace and capability structure.

# Sean Boyle: A "Business Operator" Familiar with Embolization Technology

New CEO Sean Boyle is a seasoned executive with over 20 years of experience in the medical device industry, having a career that spans multiple core areas including pharmaceutical sales, embolic materials, catheter stents, and interventional radiology businesses. He specializes particularly in scaling "validated products" for widespread implementation.

Before joining Instylla, Boyle served asVice President and General Manager of Becton Dickinson (BD) Peripheral Intervention Division, leading a multinational team managing a nearly $1 billion global revenue portfolio, covering multiple product lines such as vascular intervention, hemostasis, and embolization. He has held various sales and marketing management roles at C.R. Bard, deeply engaging in physician education, procedure promotion, and product launch pathway design. In the early stages of his career, he also worked in pharmaceutical sales at Johnson & Johnson.

In addition to his resume and qualifications, Boyle's management philosophy is also highly aligned with the stage Instylla is at. He emphasizes a "people-oriented execution culture," values team resilience, cross-team collaboration, and market feedback-driven organizational dynamic optimization.

# Current Status of the Company: Innovator at the Starting Line of Commercialization

Instylla currently has two core platform products, each at a different commercial pace:

• Tembo™ Embolization System：Absorbable particle embolic agent based on irregular dry gelatin particles received FDA 510(k) approval in January 2025, applicable for highly vascularized tumors and peripheral vascular embolization.

  

• Embrace™ Hydrogel Embolic System（HES）：Liquid embolic agent based on liquid two-component hydrogel technology has completed PMA submission and is awaiting approval for use in complex solid organ hemorrhage control and tumor interventional therapy.

The approval of Tembo marks that Instylla has completed the milestone of "technical safety and feasibility," while the advancement of Embrace represents a key strategic layout for the company in diversifying its product portfolio, expanding indications, and securing a technological edge.

At the market level, Instylla faces a highly concentrated competitive landscape, with giants such as Merit Medical, Terumo, and Boston Scientific monopolizing markets for various embolic materials including spherical particles, microspheres, and liquid carriers. Only through differentiated products and rapid implementation capabilities can the company truly break the existing pattern and establish a channel for switching doctor education and usage habits.

# From Founder to Management: Building a Three-Tier Organizational Closed Loop

Sean Boyle's arrival is not a "founder exit" scenario, but rather an organizational build-up of a three-layer capability structure working in synergy.

• The main technology remains unchanged.: Dr. Amar Sawhney continues to participate in the company's technology and direction planning as Chairman of the Board, ensuring that product development aligns with the company's vision.

• Execution Center Shift UpwardsBoyle will lead Tembo's market deployment, advance the registration of Embrace, and prepare the market, establishing an execution system centered on commercial rhythm.

• Strengthening the Senior Management: Daniel Davis, who joined as a director in early 2025, served as President of Penumbra North America and Global Commercial Officer. He brings extensive commercial experience in the embolization and neurointervention fields, strengthening the leadership on the "market + channel + physician" side.

This means that Instylla has completed the structural transition from a "founder-led R&D phase" to a "management team-led market phase" — while maintaining its original technical expertise, it has introduced commercially experienced executives with strong execution capabilities, extensive industry experience, and an international perspective.

# Industry Trend Match: Why Sean Boyle?

The current peripheral embolization market is in a phase of rapid technological evolution, expansion of indications, and deepening synergy with minimally invasive procedures:

• Technology Trends: Liquid embolic agents are beginning to replace traditional spherical materials, offering enhanced perfusion capabilities and anatomical conformity.

• Clinical Trends: Doctors are paying increasing attention to absorbable materials and postoperative reversibility, especially in indications such as liver cancer, uterine fibroids, and traumatic bleeding.

• Market Trends: Expanding from North America to the Asia-Pacific market requires higher standards for clinical education systems and registration compliance.

Sean Boyle's joining perfectly covers several core competencies that Instylla needs most in its next phase:

• Management of the Landing Rhythm for Large-scale Product Lines；

• Experience in Doctor Education and KOL Network Building；

• Registration Regulations and International Pathway Design Capability。

He not only "understands the market," but also "understands the clinical rhythm of interventional radiology," which is key to transforming Tembo into a marketable product and Embrace into guideline-level material.