A Triumph of Hope: European Medicines Agency Grants Green Light to Cellspan Esophageal Implant for Orphan Disease

In the heart of HOLLISTON, a tale of innovation unfolds on August 21, 2023. Enter Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN), a protagonist in the world of biotechnology. With every word, the stage transforms—the Company, a beacon of hope, a pioneer in the realm of organ regeneration.

A symphony of science unfolds—a melody where organs are reborn within, a remedy for the gravest of diseases. Today, a proclamation echoes—a victory claimed in the form of an Orphan Disease Application Approval. The protagonist, the Cellspan Esophageal Implant, takes center stage, celebrated by none other than the European Medicines Agency (EMA).

This is a saga that stretches beyond borders, for the EMA’s reach extends to realms as diverse as the European Union, Iceland, Norway, and Liechtenstein—a narrative where science and progress know no boundaries.

In the realm of medical miracles, a beacon of hope emerges—a gift of compassion for those battling the shadows of Esophageal Atresia. Imagine a world where children are born with hearts full of dreams but an incomplete esophagus, a tale of challenges yet to be conquered.

In this narrative, the Orphan Disease Designation (ODD) steps forward, a herald of exclusivity and possibilities. It’s a story that paints a canvas of unity—a rare condition, a shared battle, a community forged by fate. The canvas spans continents, a thread that connects lives from far corners. With a touch of magic, Harvard Apparatus Regenerative Technology becomes the guardian of dreams.

This designation isn’t just about rights; it’s a key to a realm where clinical protocols evolve and knowledge blooms. In the heart of this journey lies a beacon—a promise that for every challenge, there’s a ray of hope, a touch of healing waiting to transform lives.

In the European Medicines Agency’s realm, a golden key opens doors—a passport to a world where unity prevails and innovation knows no borders. Picture this: a single application, a chorus of voices from every corner of the European Union. The Centralized Authorization procedure stands tall, weaving dreams into a single opinion, a collective decision embraced by all. It’s not just a procedure; it’s a symphony that transforms hurdles into opportunities, where conditional approval is the dance of progress under the spotlight.

A world of protection unfolds, a shield of ten years that guards against the winds of market competition. The heroes of this tale—authorized orphan medicines—wear armor forged from dedication and innovation. But wait, there’s more—a magical extension for those who champion the cause of pediatric investigation plans, a gesture of compassion that echoes through time.

In the treasure troves of possibilities, the European Commission’s embrace beckons, funding opportunities that paint a tapestry of progress. Horizon Europe and the E-Rare ERA-NET program stand as beacons, illuminating the path for those who dare to dream big, who aim to rewrite the stories of rare diseases.

Amidst this dance of progress, voices emerge—Jerry He, the CEO, speaks of expedited journeys, of Cellspan Esophageal Implant finding its home in the European market. Dr. William Fodor, the CSO, adds his voice—a voice of assurance, a promise that innovation thrives in their hands. It’s a symphony of voices, a crescendo that echoes with hope—a tale where science and compassion unite, where innovation dances hand in hand with healing.

About Harvard Apparatus Regenerative Technology, Inc.

Imagine a world where innovation is a beating heart, and we are the pioneers sculpting its rhythm. Step into our realm—a clinical-stage biotechnology company—where science dances with compassion, each step a brushstroke on the canvas of tomorrow. Our purpose is bold: to shatter the limitations of gastro-intestinal disorders, to rewrite the narratives of cancer, trauma, and birth defects, and to unveil a symphony of regeneration that reverberates through time. In this tapestry of challenges and triumphs, we emerge as architects of possibility, forging a path where healing knows no boundaries.

Our weapon—a symphony of innovation, a cell-therapy platform that channels a patient’s own stem cells into an orchestra of restoration. Imagine a world where damaged organs find renewal, where function blooms like a phoenix rising from ashes. Our vision is simple: regeneration that springs from within, erasing the need for donor sacrifices, animal transplants, or artificial crutches. It’s a revolution painted with the brushstrokes of healing, a symphony where patients orchestrate their own recovery.

The saga began in August 2017—a feat that echoed across the medical world. In the hands of Dr. Dennis Wigle, Chair of Thoracic Surgery at the Mayo Clinic, the world witnessed the first-ever successful regeneration of an esophagus afflicted by cancer. The journals wrote our tale, the esophagus embraced renewal, a dance of tissues that whispered of hope.

Patents weave our legacy—a tapestry of 13 issued U.S. patents, 2 in China, 1 in Japan, and 2 in Europe. Our journey knows no bounds; the realm of orphan drug designations speaks of exclusivity. In the U.S., 2 issued like guardian angels, whispering seven years of protection after FDA’s nod. Across the Atlantic, EMA’s blessing paints ten years of sanctuary in the European realm.

In our story, science emerges as a hero, innovation as a beacon. Every step, every heartbeat, is a testament to the power of the human spirit—the audacity to dream, the courage to regenerate, and the symphony that heals.

Forward-Looking Statements

Within these words, a glimpse into the future takes shape—a tapestry of possibilities woven in the crucible of innovation. Hear this: our press release speaks in melodies of anticipation, with the forward-looking spirit that kindles progress. Imagine our words as seeds of hope, carried by the winds of the Private Securities Litigation Reform Act of 1995, a safe harbor where dreams take root.

In this symphony of “forward-looking” statements, our canvas is vast, painting visions of our products, of regulatory journeys navigated with hope, of collaborations birthing success. Yet, like any journey, there’s a path of risks and uncertainties, a dance with the unpredictable. A dance of challenges in funding, a symphony where regulatory approval is a coveted gem, a rhythm where collaborations and trials seek harmony. The notes of caution are as present as the notes of hope, painted in the strokes of “Item 1A. Risk Factors” in our Annual Report on Form 10-K.

But wait—there’s a twist, a revelation—a reminder that the future’s colors are known only in part, that factors we can’t foresee may take center stage. These forward-looking words are our stars, shining as beacons into the unknown.

In this chapter of our story, words are bridges connecting the present to the possible. As the ink meets the page, as the voices of anticipation fill the air, remember that these words are seeds—seeds that may sprout into realities, nurtured by time, watered by effort. As we release these words into the world, they echo like a promise—a promise to walk forward, to adapt, to innovate. For the symphony of innovation knows no end, and every note, every word, is a step toward the horizon of possibility.

Leave a Comment