Category Archives: Enable Injections

Enable Injections Receives First U.S. Food and Drug Administration (FDA) Approval

The FDA has approved the EMPAVELI Injector (enFuse®) for the subcutaneous delivery of Apellis’ EMPAVELI® (pegcetacoplan)

CINCINNATI, September 29, 2023 /PRNewswire/ — Enable Injections, Inc. (“Enable”) today announced that the U.S. Food and Drug Administration (FDA) has approved the  EMPAVELI Injector (enFuse®) for the subcutaneous delivery of EMPAVELI® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. for adults with paroxysmal nocturnal hemoglobinuria (PNH). The EMPAVELI Injector is a compact, wearable injector designed to streamline the self-administration experience with minimal disruption to patients’ daily lives.

Empaveli Injector on Body -Enable Injections

“The approval of the EMPAVELI Injector will enhance the patient experience of administering a large volume (20 mL) of subcutaneous therapy,” said Michael D. Hooven, Enable Injections’ Chairman and CEO. “Enable’s purpose is to redefine drug delivery for the benefit of patients. We are excited about achieving this milestone and are looking forward to growing enFuse® partnerships to improve the patient experience around the world.”

“The EMPAVELI Injector is the first purely mechanical, large-volume, on-body subcutaneous drug delivery device,” said Matthew Huddleston, Enable Injections’ Chief Technology Officer and Executive Vice President of Business Development. “The technology was designed while always keeping the patient at the forefront. Its simplicity empowers patients to confidently self-administer their therapy at home with greater mobility.”

The enFuse® technology allows hands-free, hidden needle drug delivery of up to 25 mL, and is designed for simplicity and to enable flexibility for at-home self-administration or in-clinic use.

Read the full release on PR Newswire, and refer to more information.

New Look, Same Mission – enFuse®

New Look, Same Mission—enFuse® Has a New Look 

Enable Injections is excited to introduce the new look for the enFuse® lid. The new enFuse lid design has an improved user interface with a streamlined dosing window and an enlarged area for branded product information.

enFuse on body delivery

The enFuse® Advantage – Flexibility

Enable Injections’ enFuse® accommodates delivery of drug and biologic products in large volumes ranging from 5 – 25 mL. Once approved, enFuse will allow EnywhereCareTM – enabling patients and healthcare providers to choose the delivery setting, ranging from in-clinic, to remote, to at-home self-administration.

The Impact of Innovation and Subcutaneous Delivery

For many patient populations, long-term treatment is imperative. For these patients, innovation has the potential to make a great impact.

One lead study investigator discussed Phase 1b results of clinical findings at the June 2022 annual meeting of the American Society of Clinical Oncology (ASCO 22)1, saying, “There is a great need among these difficult-to-treat patients for safe and effective treatment options that can delay the progression of the disease while preserving their quality of life.”

In the interview, the lead study investigator acknowledged the uptake of changing treatment methods could be a challenge to switch to subcutaneous (SC) administration while the current standard is IV therapy. However, “once adopted, this method of administration could significantly minimize the amount of time both patients and their physicians spend over the course of treatment,” the lead study investigator told The Pharma Letter. The investigator shared that the product “represents a novel potential paradigm for RRMM patients.”

Asked about SC administration, the lead study investigator said: “subcutaneous administration, and particularly using an OBDS, would allow patients to experience the benefits of treatment with [the drug] with greater convenience and less time spent receiving therapy.”

To learn more about enFuse flexibility and partnering with Enable Injections, contact us.

 

Resources

1.    Simon Wentworth. ‘ASCO 22 interview: Sanofi innovates in multiple myeloma’, The Pharma Letter. 06 July 2022. https://www.thepharmaletter.com/article/asco-22-interview-sanofi-innovates-in-multiple-myeloma

 

Russell Pagano Joins Enable Injections as VP, Regulatory Affairs

Russell Pagano Joins Enable Injections as VP, Regulatory Affairs

We are pleased to announce Russell Pagano, PhD, has joined Enable Injections as Vice President of Regulatory Affairs. Dr. Pagano will lead Enable’s enFuse® to its first regulatory submission and approval.

Enable Injections welcomes VP of Regulatory

Dr. Pagano has over 27 years of regulatory affairs experience in various sectors including the FDA, consulting, medical device start-up, and pharma. He joined Enable from Baxter Healthcare, where he was most recently the Global Regulatory Lead for their Advanced Surgery business unit. In this role, he led a team in gaining approval for new products and geographical expansion as well as supporting renewals for an approximately one-billion-dollar portfolio, including multiple combination biologic/device applications.

Prior to Baxter, Dr. Pagano held positions covering urological, neurological, orthopedic, and cardiovascular devices at the FDA Office of Device Evaluation. After the FDA, he co-founded a regulatory and clinical consulting company, MSquared Associates, in the DC area, where he served as a consultant for a variety of medical device firms until he left to become Vice President of Clinical and Regulatory Affairs at BioMimetic Therapeutics, a medical device start-up company. Russ earned a Bachelor of Science, Master of Science, and Doctor of Philosophy in Mechanical Engineering and Materials Science from Duke University.

“We are very excited to have someone with Russ’ broad background and experience in regulatory affairs, and we look forward to the value that he can add to Enable and our pharma partners.”

– Mike Hooven, President and CEO, Enable Injections.

To learn more about the enFuse, contact us.

Enable Injections Announces $215 Million Financing

New financing provides significant financial flexibility to propel growth efforts, benefitting patients, providers, and pharma partners worldwide.

CINCINNATI, OH—January 27, 2022 /PRNewswire/ – Enable Injections, Inc. (“Enable”), a company developing and manufacturing the enFuse® platform of investigational wearable drug delivery systems, is pleased to announce $215 million in Series C financing. Magnetar Capital (“Magnetar”) led the financing along with new institutional investments from GCM Grosvenor, Squarepoint Capital, Woody Creek Capital Partners, and other investors. Enable received significant continued support from existing investors including Cincinnati Children’s Hospital Medical Center, CincyTech, Cintrifuse, and Ohio Innovation Fund.

Enable Injections’ enFuse® is an innovative drug delivery technology designed to subcutaneously (SC) deliver large volumes of up to 50mL for a wide range of therapies and diseases, and to provide patients and providers a safe, convenient, and cost-effective alternative to IV administration. With improved flexibility for patients and providers, enFuse is designed to enable an increase in healthcare provider efficiencies, minimize patient exposure in the clinic, and reduce healthcare costs, with the aim of benefiting patients and healthcare providers worldwide.

Enable Injections-enFuse-drug-delivery-innovation

“Enable Injections has seen a dramatic increase in demand for enFuse’s high-volume drug delivery technology. The funding from Magnetar will help enFuse continue to redefine intravenous drug delivery by meaningfully scaling our development and commercialization efforts. This will help us reach even more patients who depend on intravenous medications and, we believe, significantly improve their lives,” said Mike Hooven, President and CEO, Enable Injections. “Magnetar, and its healthcare team, bring valuable industry expertise and an extensive network of financial and biotech contacts to Enable. We are excited to partner with Magnetar to grow the enFuse platform globally and achieve our shared vision of supporting next generation patient-healthcare provider connections through an enhanced injection administration experience.”

“This financing will provide additional resources to onboard important new pharma partner programs and accelerate our commercialization programs and platforms with existing pharma partners,” said Tim Flaherty, EVP and CFO, Enable Injections. “Enable is a stronger company with Magnetar as a strategic partner, with its thoughtful approach to healthcare investing.”

UBS Securities LLC served as exclusive placement agent to Enable Injections in connection with this financing.

About Enable Injections:

Cincinnati-based Enable Injections is an investigational-stage company developing and manufacturing on-body subcutaneous drug delivery systems designed to improve the patient experience, support superior outcomes, and advance healthcare system value and economics. Enable’s body-worn enFuse® drug delivery platform utilizes standard container closure systems to deliver high-volume pharmaceutical and biologic therapeutics. For more information, please visit www.enableinjections.com.

About Magnetar Capital:

Founded in 2005, Magnetar is a multi-strategy alternative investment manager with approximately $13.5 billion of assets under management as of September 30, 2021. Magnetar seeks to achieve stable risk-adjusted returns by opportunistically employing a wide-range of alternative credit and fixed income, energy and infrastructure, and systematic investing strategies. Magnetar invests across regions and business structures, in both public and private markets, taking advantage of the deep rigor of fundamental and quantitative analysis. The firm is based in Evanston, Illinois, with additional offices in London and Houston. For more information, visit www.magnetar.com.

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What Is Enable Injections’ Superpower?

The Enable team is made up of passionate, entrepreneurial, and driven people who are working with a common goal of improving the lives of patients. In this brief video, we asked our team to share what they believe is Enable Injections’ superpower.

We are Enable and we are superheroes. Read more about our team here.

Follow us on LinkedIn for the latest updates, or contact us!

Enable Injections: Our Story and Team Culture

About Enable Injections

Enable Injections is a Cincinnati-based investigational-stage company developing and manufacturing novel on-body injection systems designed to support improved outcomes, patient experience, and healthcare system value. The enFuse® delivery system is being designed for convenience and allowing patients and healthcare providers flexibility in administering treatments.

The Enable team partners with pharmaceutical and biotech companies to develop the enFuse® delivery system paired with a therapeutic. Enable team members are technology experts in roles such as product development, research and development, regulatory affairs, quality, and manufacturing with the primary focus to deliver an exceptional patient experience in collaboration with our biopharma partners. The enFuse® connectivity is being developed to allow patients the opportunity to remain connected to their physician while receiving treatments at home.

wearable injector enFuse

Enable Injections enFuse®

Enable Team Recognition

Our experienced Executive team has successfully launched Medical Device start-ups before Enable, including CEO, Mike Hooven, who founded Atricure.

Other organizations are taking notice of our work. Recently, Enable Injections was the proud recipient of the 2020 Innovation and Technology Award from the Business Courier. Click here to see a list full list of recent awards.

Enable Culture

The Enable team is made up of passionate, entrepreneurial, and driven people who are working with a common goal of improving the lives of patients. The work environment is described as fast-paced, challenging, and dynamic – no two days are the same. Although we are experiencing tremendous growth, you can still feel the start-up energy buzzing throughout our facilities. It is our priority to stay connected as a team and within our community. In 2019, the Enable team dedicated an entire workday to doing projects serving the local community, pictured below.

 

Enable Injections Service Day 2019, Habitat for Humanity

Service Day 2019, Habitat for Humanity

At the end of 2019, we rang in the holiday season together at Fretboard – a local brewery.

 

Holiday Celebration 2019, Fretboard

Holiday Celebration 2019, Fretboard

 

2020 has looked a bit different, but despite the pandemic, we continue to find ways to stay connected and pressing toward our goals.

Enable Injections Response to COVID-19

In the face of COVID-19, Enable is working hard to protect its employees and their families from exposure to the virus. To maintain the safest and healthiest work environment, we implemented new policies and procedures, including:

  • Increased Office Cleaning
  • Updated Employee, Non-Employee Visitor Protocols
  • Staggered Break Times
  • Modified Office Layout to accommodate social distancing
  • Set Room Capacity Limitations
  • Remote and Partial work-from-home, as appropriate
  • And we continue to find ways to improve sanitation and safety practices

Although 2020 presented unique challenges, the Enable team has done a terrific job adjusting to the new circumstances and has embraced the new protocols to keep each other safe. Despite the shutdown in early March, Enable was deemed an essential business and continued to run a successful operation while keeping employees safe.

With new protocols in mind, team celebrations may look different, but we are finding creative ways to stay connected through virtual means, celebrate our milestones safely, and most importantly – support each other. To recognize our most recent accomplishment – a successful and timely clinical build – the Executive Team distributed a gift basket and a personal congratulatory note to each employee.

Enable Injections

Employee Recognition Gift

Enable Team Benefits and Opportunities

Enable offers excellent benefits and rewards to our team of employees. Our benefits package includes Medical (PPO or HSA), Dental, Vision, and Life insurance, as well as short and long-term disability, and an employer-sponsored 401k plan, with match, to all eligible employees. We also have an annual bonus and competitive time off program.

We continue to add new members to our growing team, check out Enable’s current openings here! Contact us to learn more.

Follow us on LinkedIn and Twitter for the latest updates.

Letter from Mike Hooven, CEO, Enable Injections

Letter from Mike Hooven

18 MAY 2020

The current state in which we now live is one we could not have imagined three months ago. The Coronavirus pandemic is impacting the way we live our lives, as a global community, and as a country, on both corporate and personal levels. It is now more important than ever to find a way to continue our lives closer to home, including taking prescribed therapies. This current situation is raising the stakes on the importance of our work at Enable Injections.

Due to the Coronavirus pandemic, the availability and safety for patients to receive infusions at a healthcare facility or via a home health care provider has changed swiftly. Patients may be faced with being unable to receive their therapeutics in the way they previously received them. Pandemic measures have caused healthcare resources to shift and facilities to refocus care. Limits on social contact and mandatory distancing have impacted patient care in unprecedented ways.

Enable Injections enFuse

Enable Injections enFuse®

Even before the Coronavirus pandemic, Enable Injections had a goal to change the future of healthcare by finding a solution for patients to receive their therapy outside of the clinic. Enable will continue to press on in our development of innovative infusion technologies in conjunction with our pharmaceutical partners to achieve this goal.

In the weeks and months to come, all of us at Enable will be committed to continuing forward with an unwavering and unrelenting focus on our goal – to improve the lives of patients and to change the future of infusion that will someday bring infusion closer to home.

Contact us to learn more about the enFuse patient-focused technologies under development.

New Press on enFuse®

Enable Injections is pleased to share several notable events this February, including a new published articles (Forbes is writing about Enable!), and a new award.

 

Drug Delivery Designed to Improve the Patient Experience 

Citation: King J, “Drug Delivery Designed to Improve the Patient Experience”. ONdrugDelivery Magazine, Issue 105 (Feb 2020), pp 52-55.

Enable Injections takes a look at the delivery challenges of novel therapies for chronic diseases using a specific patient’s story as an example, going on to highlight the ways in which a novel device approach could make all the difference for patients.

Drug Delivery Designed to Improve the Patient Experience

Drug Delivery Designed to Improve the Patient Experience – OnDrugDelivery February 2020

Chronic illness touches everyone, it seems. Whether it is a family member, friend or co-worker, many people have some understanding of how difficult life can be while managing a chronic disease. The biotech revolution has led to many novel therapies that are changing lives. But these new therapies may come with delivery challenges that make it difficult for a patient to receive treatment. When a patient shares stories of the rigours they endure to manage their disease, it highlights the motivating factor behind novel technology like the enFuse on-body infusor platform.

ODD-graphic-1

A REAL PATIENT WITH A REAL STORY

The Enable Injections team recently spent time with a patient who introduced an interesting perspective on her infusions. Megan has managed a chronic autoimmune disease for more than 15 years. She is passionate about helping others who live with similar autoimmune diseases – especially young people, because she was diagnosed at the age of 18.

Megan was initially prescribed 28 pills per day for treatment, which proved to be difficult to manage and ineffective. While planning her life around her dosing schedule, she lived in a mental fog due to fatigue and was unable to travel or do other activities she loves.

At the age of 23, she began seeing a new doctor who said to her: “You are a young person and you deserve to live your life.” Megan said hearing those words was life-changing, as she thought she would never feel well again. Her new doctor prescribed a new therapy via IV administration, and she began feeling better. Even though she was required to take an afternoon off work for each treatment, she didn’t mind the inconvenience. She began to think of the three hours tethered to the IV as “me time” because the hospital infusion centre was comfortable and, over time, she came to know the staff. However, each infusion had the potential for its own challenges.

ODD-graphic-3

Read more at OnDrugDelivery.

 

enFuse® Wins a GOOD DESIGN Award

Enable Injections is pleased to announce the enFuse® has won a GOOD DESIGN® Award 2019.

Founded in 1950, GOOD DESIGN® is the world’s most prestigious, recognized, and oldest Design Awards program organized annually by The Chicago Athenaeum Museum of Architecture and Design in cooperation with the European Centre for Architecture, Art, Design and Urban Studies.

enFuse® Wins a GOOD DESIGN Award

enFuse® Wins a GOOD DESIGN Award

 

Forbes Is Talking about Enable Injections

New Forbes article, February 2020 – “Marketing to 100-Year-Olds: How Longevity Will Transform Finance, Healthcare and Education”

Forbes-article-FEB2020

 To learn more about Enable Injections and the enFuse® On-Body Platform, contact us.

enFuse® Featured in Forbes: This Pharma Startup Could Transform How Chronic Diseases Are Treated

Throughout 2019, SAP has helped to spread the Enable Injections story and the potential for the enFuse to impact patients. We are delighted to be partnering with SAP and leveraging their software solutions as we grow, scale, and prepare for commercialization.

Enable Injections CFO, Tim Flaherty, has appeared many times at SAP events to share the Enable story. In addition, SAP produced a video sharing the patient perspective.

Patient video - Enable Injections and the enFuse, SAP, Dickinson + Assoc.

Watch the 2-minute video by clicking here.

This week, the enFuse story appeared on Forbes.com. Please read below for the link and an excerpt written by Tricia Manning-Smith, SAP:

enable-injections-enFuse-index-committed-to-you

This Pharma Startup Could Transform How Chronic Diseases Are Treated

By Tricia Manning-Smith, SAP

The needle is so tiny, you almost have to hold it up to the light to see it. It’s the size of three hairs held together. This miniscule needle, and its supporting medical technology, might change the future for many chronic disease patients.

Yet, because the needle is hidden inside an unprecedented med-tech device, patients will never actually see it. A patient will stick the yo-yo sized device on her abdomen and the needle stays hidden inside. She then simply pushes a button to self-administer her medication.

“There’s nothing like it in the world,” said Tim Flaherty, CFO and spokesman for Enable Injections. He explains that the startup company’s device is currently undergoing clinical trials before attaining the final FDA approval.

Flaherty shows the device to visitor Megan Starshak, a chronic disease sufferer, as they tour the company’s Cincinnati, Ohio-based research and production facility. “The device doesn’t feel clinical and scary,” said Starshak. She knows a great deal about needles and pain.

When Starshak was 18, a doctor diagnosed her with the chronic autoimmune disease, Ulcerative Colitis (similar to Crohn’s Disease). Since then, Megan has tried every treatment available to ease her symptoms, which include chronic fatigue, urgent bowel movements and abdominal pain.

“My highest pill count per day was 28,” said Starshak who now visits a clinic for a nurse-administered IV that injects medication directly into her veins. “At the time, the IV was my last option to avoid surgery.”

Read the article at Forbes.com by clicking here

Scaling for Success: Why Enable Injections Is the Earliest-Stage Adopter of SAP

Many of us have someone close to us who receives intravenous (IV) therapies at a hospital or healthcare facility. For example, we heard last week of a ten-year-old boy who needed his monthly infusion for his rare disease, but he missed his appointment. It wasn’t the first time. He told his infusion nurse that he was not sad when his mother forgot the infusion appointment. He didn’t remind his mom because he hates going to get his IV infusion. But a few days later, when he began to show symptoms and felt poorly, they had to return to the hospital to make up the infusion.

On that makeup infusion, the boy was so upset that the whole procedure had to be delayed while one of the hospital therapy dogs was called to help. Eventually, the boy received his IV treatment with no other issues and was able to leave for home about six hours after he arrived at the hospital. As usual, he would have to make up his schoolwork, and would plan to return to the infusion chair in two weeks for yet another infusion.

For those of us at Enable Injections, these are the stories that move us to do what we do – we are working to provide patients with a new way to receive their therapy.

Enable Injections and Growth

Enable Injections, Inc., founded in 2010, has been developing the enFuse®, an innovative on-body infusor. Enable believes that the enFuse is one of the promising technologies emerging in medtech, specifically because it is designed to allow patients to self-administer therapeutics at home which may have otherwise required a visit to a healthcare facility.

Pharmaceutical Partnerships

Pharmaceutical companies partner with Enable Injections for specific therapeutics to be delivered via the enFuse. Enable’s first partnership began in 2014, and now, halfway through 2019, Enable has six partnerships.

To prepare for the rapid growth needed to serve these partnerships and the ones to come, Enable’s leadership decided to invest resources for implementing an Enterprise Information Technology (IT) system. While still in the start-up phase, Enable chose SAP to help guide and scale the growth of the company and became the earliest adopter of the SAP system.

Why SAP and Why So Early?

Enable decided on SAP’s Enterprise IT system because of its 1) phased approach, 2) seamless integration plan, 3) flexible module implementation, and 4) pharma industry positioning, and 5) scalability. SAP is an enterprise software globally known for helping businesses to scale and grow efficiently. About 85% of Enable’s pharmaceutical partners use SAP.

With Enable’s enFuse serving as the device constituent part of a combination product, the product development process through approval and beyond performs more seamlessly with partners when using the same Enterprise IT system.

When a potential partner asks which Enterprise IT system we use and whether we have controls and manufacturing software systems, we answer SAP. To date, every pharma partner has been pleasantly surprised, based upon the stage of the company.

One reason Enable Injections chose SAP is for its capability in tracking manufactured products according to FDA regulations.

Enable wanted to avoid beginning with a smaller capable ERP system and switching to a more robust system later. Enable started with SAP’s S4 Hana model to prevent having to switch in 3 or 5 years to a different package.

Tim Flaherty, CFO Enable Injections, Speaker at SAP Sapphire Conference, May 2019

Tim Flaherty, CFO Enable Injections, Speaker at SAP Sapphire Conference, May 2019

The SAP Implementation Details

To implement the SAP package, Enable utilized a phased approach1. Enable used a software leasing company2 to spread the licensing over 36 months. The S4 Hana model offering includes implementing financials (phase 1), quality / onboard training and human resources (phase 2), product lifecycle management, plant maintenance, recruiting, onboarding, and warehouse management (phase 3).

Enable Injections engaged with SAP to leverage its Life Science best practices and implement a platform to support the company’s projected growth with potential to scale to a multi-billion-dollar manufacturing company.

We look forward to making a difference for patients.

 

Authors:

Jennifer King, Marketing Manager, Enable Injections

Tim Flaherty, EVP & CFO, Enable Injections

 

References:

1: Dickinson + Associates: https://www.dickinson-assoc.com/

2: Winthrop, https://www.winthropresources.com/