Category Archives: Uncategorized

Enable Injections Announces Plans to Expand Manufacturing Facilities and Corporate Headquarters

New state-of-the-art facility to be located in Springdale, Ohio

Expansions will support ongoing clinical and commercial supply of Company’s enFuse technology 

CINCINNATIFeb. 14, 2024 /PRNewswire/ – Enable Injections, Inc. (“Enable”), a leading innovator in developing and manufacturing the enFuse® platform of wearable technology, today announced it plans to expand manufacturing operations with a new large-scale facility in Springdale, Ohio as well as enhance the Company’s corporate headquarters in Evendale, Ohio.

The Company’s new 90,000 square-foot Manufacturing Center of Excellence will support ongoing in-house manufacturing and supply of the Company’s enFuse medicine delivery technology. enFuse is the first-ever hands-free wearable technology that allows patients to self-administer large-volume medications subcutaneously without an IV or syringe pump.

“Scalable, in-house manufacturing is a key pillar of Enable’s strategy to accelerate supply of our innovative enFuse technology as the Company continues to grow our roster and scope of clinical and commercial engagements with pharmaceutical partners. This new facility allows Enable to significantly expand and enhance production processes and ultimately reduce the time it takes to bring our enFuse system to patients and the medical community,” said Mike Hooven, Chairman and CEO of Enable Injections. “We are proud to have grown our business in Ohio over the last decade and are thankful for the continued support from the state and local organizations as we expand our business operations and footprint.”

The commitment to increase the Company’s manufacturing facilities and capabilities follows U.S. FDA approval and launch of the Company’s first enFuse combination product.

Enable expects to begin occupying its new Manufacturing Center of Excellence by the end of 2024. As the facility becomes operational, the new location and Evendale headquarters will retain and add more than 450 jobs over the next ten years to the Cincinnati area. The State of OhioJobsOhio, the City of Evendale, the City of Springdale, and REDI Cincinnati provided support for Enable’s expansion.

“We and our partners at REDI Cincinnati welcome Enable Injections’ decision to grow operations in the U.S. and bring new career opportunities and investment to Ohio,” said JobsOhio President and CEO J.P. Nauseef. “Enable is a global leader in drug delivery, improving the lives of patients worldwide, and we look forward to a continued partnership.”

In addition to the new Manufacturing Center of Excellence in Springdale, Enable will be renovating and enhancing the infrastructure of its Evendale headquarters. The Company’s headquarters presently houses GMP-compliant manufacturing space to support current clinical and commercial demand of enFuse, as well as labs and administrative areas.

View the original press release on PR Newswire.

Enable Injections Appoints David Kroekel as Chief Operating Officer

– Promotion supports commitment to continued manufacturing and product development success for enFuse® platform – 

CINCINNATIFeb. 7, 2024 /PRNewswire/ – Enable Injections, Inc. (“Enable”), a leading innovator in developing and manufacturing the enFuse® platform of wearable drug delivery systems, today announced the appointment of David Kroekel, previously Senior Vice President, Product Development and Operations at Enable, to Chief Operating Officer. In this critical position, Mr. Kroekel will play an important role leading the ongoing engineering, manufacturing, and supply of the Company’s enFuse technology.

“David brings a wealth of experience in cross-functional collaboration, infrastructure development, and engineering excellence in medical device manufacturing and development,” said Mike Hooven, Chairman and CEO of Enable Injections. “In the past year, Enable has poised itself for long-term commercial success and increasing product demand – with the U.S. FDA approval of the Company’s first enFuse combination product, and three high-value collaborations with both new and existing partners. David’s leadership at Enable has played a pivotal role in our Company’s success to date and we are excited to have him in this new position as COO as we continue driving innovation for enFuse and bringing this game-changing technology to our partners, HCPs, and most importantly – patients.” 

Enable Injections Appoints David Kroekel as Chief Operating Officer Davidkroekel11x14-dsc1068 Enable Injections

Mr. Kroekel has more than 35 years of experience in medical device, combination product operations, and product development. Prior to Enable, Mr. Kroekel was the Biomedical Global Head of Operations at DSM Biomedical, responsible for global leadership of biologics and medical materials manufacturing, and also previously served as the Sr. Director of Innovation, where he led new product development and innovation. Prior to DSM, Mr. Kroekel held various senior positions in the medical device industry for companies like Flowonix Medical, Teleflex Medical, and Arrow International’s EMEA business unit in Belgium. Mr. Kroekel earned a Bachelor of Science in Mechanical Engineering from Pennsylvania State University and a Master of Science in Manufacturing Systems Engineering from Lehigh University. 

“As the first-ever hands-free wearable technology that allows patients to self-administer large-volume medications without an IV or syringe pump, enFuse is a breakthrough in meeting patient needs with new and innovative solutions. I look forward to leading and advancing how our manufacturing and product development teams increase the capabilities and efficiencies in delivering our wearable technology to more patients,” said David Kroekel, Chief Operating Officer of Enable Injections.  

This strategic leadership reinforcement follows the recent U.S. FDA approval and launch of the Company’s first enFuse combination product. 

Enable is currently working with a number of pharma partners to conduct clinical trials and planning for joint commercial launch of their therapies in combination with the enFuse technology. The Company continues to selectively add to its list of pharmaceutical partners, with indications and patient populations who will benefit from the enFuse system. 

View the original press release on PR Newswire.

Beyond the Point: Navigating the Impact of Needles on Pain, Anxiety, and the Patient Experience

From ONdrugDelivery January 2023:

Over the last decade, the subcutaneous (SC) administration of therapeutics has experienced significant growth, emerging as a widely accepted option for drug delivery. The shift from intravenous (IV) infusions to SC injections has not only reduced the drug administration burden on the healthcare system, but is also generally preferred by patients and healthcare practitioners (HCPs).1–4 This positive impact has led to intensified research aimed at understanding the key elements of the SC administration process, such as the impact of needle size, needle phobia and environment, on the overall patient experience.

The choice of needle size can significantly influence the patient experience, particularly when larger diameters are employed. Larger needle diameters have been associated with heightened levels of pain and anxiety in patients, casting a shadow across the overall quality of care. The discomfort induced by needles not only amplifies the immediate physical sensations, but also contributes to long-lasting psychological repercussions, potentially leading to or exacerbating needle phobia.

 

Needle phobia, characterised by an intense fear and anxiety of needles, is a prevalent concern that further complicates the patient experience. The widespread prevalence became evident in a recent global survey conducted among a general adult population (N = 2,098), where 63% of participants reported experiencing needle phobia.5 Individuals afflicted by needle phobia may exhibit heightened anxiety, increased heart rate and even avoidance behaviours. Aversion to needles not only poses challenges for HCPs but also jeopardises the overall wellbeing of patients, as essential treatment may be delayed or avoided altogether.

When delving into the impact of larger needle diameters, needle phobia and the environment on the patient experience, it becomes imperative to explore strategies and innovations that mitigate these adverse effects. By understanding the psychological and physiological dimensions of needle-related distress, HCPs and injection-system manufacturers can begin to tailor interventions to minimise pain, alleviate anxiety and enhance the overall SC administration experience for patients.

NEEDLE SIZE AND PAIN

The impact of needle size on pain during SC administration is a critical consideration, as highlighted in research by Arendt-Nielsen et al and Præstmark et al.6,7 These studies emphasise the significant correlation between the outer needle diameter and the frequency of pain, shedding light on the direct relationship between needle characteristics and the patient experience.

 

Beyond the Point: Navigating the Impact of Needles on Pain, Anxiety, and the Patient Experience Ondrugdel-pfs-jan2024-enable-injections Collage Enable Injections

Read more at ONdrugDelivery.

Enable Injections Enhances Board with Addition of Vickie Capps

New director, Vickie Capps, brings comprehensive financial expertise and leadership experience to Enable Injections, serving as head of the audit committee.

CINCINNATI, OH—November 7, 2023 /PRNewswire/ – Enable Injections, Inc. (“Enable”), a company developing and manufacturing the enFuse® platform of wearable drug delivery systems, is pleased to announce the appointment of Vickie Capps to the company’s Board of Directors as the head of the audit committee.

Enable Injections Enhances Board with Addition of Vickie Capps Vickie Capps Headshot Enable Injections

Vickie has had a distinguished career in finance and executive leadership with extensive board experience. In addition to Enable, she currently serves on the boards of other healthcare and life sciences companies, including Amedisys, Inc. and Janux Therapeutics, Inc., as well as several other past board positions. She is also a member of the Senior Advisory Board of Consonance Capital Partners, a healthcare focused private equity firm. Vickie previously served as chief financial officer of DJO Global, Inc. from 2002-2013. She is a Certified Public Accountant, and she received her B.S. in business administration and accounting from San Diego State University.

“The enFuse technology could make a significant impact on the drug delivery industry and how patients receive life-altering medication,” said Vickie Capps. “I’m excited to be part of this innovative company and I look forward to working with the team on increasingly meaningful milestones in the future.”

“Vickie brings a wealth of experience and financial acumen to our Board at a pivotal stage for Enable Injections,” said Mike Hooven, Chairman and CEO of Enable Injections. “Her expertise in global business operations, corporate finance and accounting, capital markets, and investor relations will help to drive Enable forward as we enter the next phase of commercialization as a company. We are thrilled to welcome her to the Enable team.”

The appointment of Vickie Capps increases the size of Enable’s Board to ten members with a wide range of business, pharmaceutical, and medical device backgrounds. This announcement follows the recent U.S. FDA approval of the EMPAVELI Injector based on Enable Injections’ enFuse technology.

View the original press release on PR Newswire.

The Call for Freedom – A Patient’s Perspective on Today’s Drug Delivery Systems

More than 133 million people in the United States live with a chronic disease2, which is defined as a “condition that lasts one year or more and requires ongoing medical attention or limits activities of daily living or both.”1 Pharmaceutical companies create medications to address health concerns, but treatment options can lack convenience and ease-of-use for patients. Many of these life-changing treatments must be delivered parenterally, or through intravenous (IV) or subcutaneous routes of administration, to bypass the digestive system, and be effective for the patient. But this type of delivery has challenges, often including poor ease-of-use, larger needles,  visible needles, and more. While patients often regain their health from these therapeutics, current delivery options take additional time and resources.  From long infusions in an IV chair in the clinic to cumbersome processes for patients to navigate on their own at home, these challenges often create burdens for patients.

Meet Rebecca

The Call for Freedom – A Patient’s Perspective on Today’s Drug Delivery Systems Meet Rebecca Enable Injections

Rebecca is a wife, a mom to a teenage daughter, a healthcare professional, and is one of the more than 133 million people in the US living with a chronic disease. She was diagnosed with Common Variable Immunodeficiency Disorder (CVID) 15 years ago. CVID is “a primary immune deficiency disease characterized by low levels of protective antibodies and an increased risk of infections.”3 Patients of CVID are known to face additional health challenges such as bronchitis, other autoimmune disorders, digestive disorders, and solid tumor cancers.4

For Rebecca, the road to treatment was long and difficult. A bout of pneumonia in her early twenties started the journey and continued into her thirties when she was diagnosed with fungal sinusitis. Doctors suspected there may be an underlying cause of Rebecca’s illnesses, but it was not for another 10 years until Rebecca was able to receive her CVID diagnosis. Even with the diagnosis, Rebecca faced years of doctors’ visits and failed rounds of antibiotics until she was finally able receive insurance approval for her subcutaneous IgG infusions.

Managing Chronic Illness Today

The Call for Freedom – A Patient’s Perspective on Today’s Drug Delivery Systems Rebecca With Pump Enable Injections

While Rebecca’s subcutaneous IgG infusions have made a largely positive impact on her health, the management of these treatments takes a large mental, emotional, physical, and economic burden on Rebecca and her family. After just one demonstration with a nurse practitioner, Rebecca began infusing weekly with a handheld pump.

To complete her infusions, Rebecca starts by loading the medication into her pump with a handheld syringe. She then takes two butterfly needles, about an inch long apiece, and proceeds to “pinch an inch” of her abdominal tissue to be able to insert the needles. The fear and anxiety from inserting a needle into yourself is something Rebecca says she had to learn to work through. The fear of needles, Trypanophobia, affects up to 25% of US adults, some of which may avoid infusion treatments altogether due to symptoms such as panic attacks, nausea, palpitations, and fainting.5

After the needles are inserted, Rebecca must tape these needles down to ensure they are secure. Because of the additional tubing that connects the needles to the pump, Rebecca must lie immobile for at least an hour while her administration completes to avoid the tubing catching on normal household objects, a painful experience Rebecca does not want to repeat. Because the current pump forces medication into her tissue at a constant rate, it can still lead to an abundance of injection site discomfort.

From start to finish, Rebecca’s infusions take up to 2 hours; however, the time commitment required for her infusions also include scheduling her infusions and managing the supplies. Rebecca’s infusion regimen forces her to plan her life – travel, work, mom duties – around her infusions.

Rebecca’s current infusion system is unwieldy, expensive, and robs her of precious time she could be spending living her life. When asked what it would mean to her to have options, she said, “It would take a great strain off my mind to be able to have other options, which today I don’t.”

enFuse® Enables Freedom

The Call for Freedom – A Patient’s Perspective on Today’s Drug Delivery Systems Rebecca Holding Enfuse With Approval Statement Enable Injections

“When I look at the enFuse, I think of freedom.”-Rebecca

Rebecca is passionate about improving the patient experience and was intrigued when she heard about the innovative enFuse delivery system. After seeing the enFuse and completing a demonstration, Rebecca had this to say, “This [enFuse] is smaller. It’s easier to handle. So many less supplies to have to worry about. And I don’t have to see the needle, which is the best part. It seems very simple to use. It’s very intuitive… and it was so fast. That’s what I love about it. You can be infusing in under 2 minutes, go to the grocery store, go to the track meet. Nobody has to even know.”

The current standard of care for at home SC infusions comes with many challenges that take a toll on the patient. The enFuse from Enable Injections has the potential to alleviate many of these challenges, improving the patient experience, and giving people like Rebecca their lives back. To hear Rebecca’s full story, watch here: https://youtu.be/Vr0HBexg-Ac

 

  1. “About Chronic Diseases.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 21 July 2022, www.cdc.gov/chronicdisease/about/index.htm.
  2. Raghupathi, Wullianallur, and Viju Raghupathi. “An Empirical Study of Chronic Diseases in the United States: A Visual Analytics Approach.” International Journal of Environmental Research and Public Health, U.S. National Library of Medicine, 1 Mar. 2018, www.ncbi.nlm.nih.gov/pmc/articles/PMC5876976/.
  3. “Common Variable Immunodeficiency (CVID).” National Institute of Allergy and Infectious Diseases, U.S. Department of Health and Human Services, www.niaid.nih.gov/diseases-conditions/common-variable-immunodeficiency-cvid#:~:text=Common%20variable%20immunodeficiency%20(CVID)%20is,an%20increased%20risk%20of%20infections. Accessed 13 Oct. 2023.
  4. Odnoletkova, Irina, et al. “The Burden of Common Variable Immunodeficiency Disorders: A Retrospective Analysis of the European Society for Immunodeficiency (ESID) Registry Data – Orphanet Journal of Rare Diseases.” BioMed Central, BioMed Central, 12 Nov. 2018, ojrd.biomedcentral.com/articles/10.1186/s13023-018-0941-0.
  5. Robert H. Shmerling, MD. “Terrified of Needles? That Can Affect Your Health.” Harvard Health, 27 Apr. 2021, www.health.harvard.edu/blog/terrified-of-needles-that-can-affect-your-health-2021042722470.

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.

A New Frontier: Self-Administration of Lyophilized, Large-Volume Subcutaneous Biologics

From ONdrugDelivery September 2023:

Biologics are the mainstay of therapy for a growing number of diseases, as they can provide more effective and targeted treatment than traditional therapies. These drugs are often composed of living organisms or their by-products. The most common format for a biologic drug is a monoclonal antibody (mAb). Biologics, specifically mAbs, can be bioengineered to improve the safety, efficacy, half-life, potency and other characteristics of therapies, which makes them particularly attractive to drug developers.

Since the approval of the first biologic in 1986, the number of biologic drug approvals and submissions has increased steadily. Antibody drugs have taken the spotlight with a steady growth in approvals over the decades in both intravenous (IV) and subcutaneous (SC) formats. A review by Strickley and Lambert published in 2021 shows that, of the 136 antibodies identified, 47 were SC (34.5%), 85 were IV (62.5%) and the remainder used other delivery routes (3%). The review highlighted that 100 were a liquid solution (73.5%) and 36 were lyophilised (26.5%).

LYOPHILISATION – PROS AND CONS

Over a quarter of all mAbs are lyophilised, which is likely due to stability challenges. Similarly, many peptides are also lyophilised due to their high sensitivity to temperature and shear forces. For example, in antibody-drug conjugates (ADCs), the linker is usually a peptide, so in order to minimise the instability associated with the linker, all US FDA-approved ADCs are lyophilised. Given the complexity of mAbs and their sensitivity to changes, bioengineering to improve mAb characteristics can often come with physical stability challenges.

mAb drugs are susceptible to conformational changes, protein aggregation and other stability issues. These issues can be caused by changes in temperature, the addition of certain excipients and buffers and other factors. These obstacles are exacerbated when trying to create a highly concentrated format, since protein aggregation is concentration dependent. Trying to develop a high-concentration, low-volume mAb formulation for SC injection is possible; however, it can be time- and labour-intensive, which can delay the clinical trial timeline. If a high-concentration liquid formulation is successfully designed for all characteristics except aggregation, then lyophilisation may be the best approach.

In addition to its benefits on the formulation process, lyophilisation can also simplify shipping and handling of drugs by eliminating the need for cold chain storage and reducing the weight and volume of the drug. Since lyophilisation removes water from the product, it can also increase the shelf life of drugs as the lack of water creates a challenging environment for microbial growth and chemical reactions.

However, while lyophilisation can solve stability issues, it can have negative downstream implications pertaining to patient preference, drug wastage, delivery device selection (if SC delivery is desired) and human risk factors. The need for a diluent for a lyophilised drug adds complexity and the reconstitution process introduces increased time requirements and the potential for human error into the process, which is especially impactful if patient self-administration is the goal. This additional step makes delivering lyophilised drugs with standard syringes and autoinjectors challenging for self-administration.

This leads manufacturers to options that limit SC delivery volumes (<5 mL), such as complex dual-chamber syringes. Because these dual-chamber syringes use a new storage container for the drug, changing away from the original vial, the developer must go through primary container testing.5 In other words, because the drug is now being stored in the syringe chamber and not in the vial, additional work must be done on the new container, which is cost- and time-intensive.

“The enFuse DVT system is designed to provide a simpler solution to the reconstitution step, which is the largest source of error among patients self-administering lyophilised drugs.”

LARGE-VOLUME SC FORMULATIONS

While lyophilisation of high-concentration formulations is a viable strategy to reduce the risk of aggregation, aggregation risk may also be mitigated by reducing the concentration and increasing the volume of the formulation. Reducing concentration and increasing volume would typically result in a drug formulation in the 5–25 mL range. There is a common, unsubstantiated belief that volumes this high cannot be administered subcutaneously without a permeation enhancer. However, large-volume SC biologic drugs, such as SC immunoglobulin (25 mL per site on the abdomen), and evolocumab (3.5 mL) were approved and successfully administered for years prior to the introduction of permeation enhancers.

In recent years, multiple large-volume SC drugs have been approved and are successfully administered without a permeation enhancer, including pegcetocoplan (20 mL), ravulizumab (7 mL), rozanolixizumab (3–6 mL), and others still in development. While permeation enhancers may increase absorption, they have not demonstrated a significant impact on bioavailability in prospective human trials. Delivering these drugs via a syringe, in combination with hyaluronidase, does not allow for patient self-administration and has led to musculoskeletal issues in nurses after repeated administration.

When considering the large volume of 5–25 mL in the context of patient self-administration, only two delivery options exist: Enable Injections’ enFuse® or a SC syringe pump. enFuse is the first purely mechanical on-body delivery system with an original container closure and flexible dosing capability and, in a recent study, enFuse demonstrated unanimous patient preference in all surveyed patients versus a SC syringe pump. Patients stated their outstanding preference for the enFuse was due to ease-of-use, increased mobility during infusion, reduced setup time and reduced pain at the injection site. If lyophilisation is necessary for the structure of the drug, or if the other benefits of lyophilisation are desired, the enFuse has multiple modalities that are designed to enable self-administration of lyophilised large-volume SC biologics.

 

RECONSTITUTION WITH CURRENT ENFUSE TECHNOLOGY

A New Frontier: Self-Administration of Lyophilized, Large-Volume Subcutaneous Biologics Figure 1-syringe Transfer Enable Injections

The enFuse system consists of an on-body delivery device coupled to a transfer system, provided to the end user in sterile packaging. The enFuse transfer systems currently consist of a syringe transfer (ST) system and a vial transfer (VT) system. Additionally, a dual vial transfer (DVT) system is currently in development to support other large-volume SC applications, including lyophilised biologics. The ST system uses a prefilled syringe or a user-filled syringe to transfer the drug product into the enFuse. The user presses down on the syringe to initiate the transfer.

In contrast, the VT system has the user insert a single vial into the system, after which the drug product is automatically transferred into the enFuse. This provides optionality, as manufacturers can choose the system that best suits the needs of their patient population. Both systems can be used for self-administration of lyophilised drug products.

A New Frontier: Self-Administration of Lyophilized, Large-Volume Subcutaneous Biologics Figure 2-vial Transfer Enable Injections

The lyophilised drug product would be reconstituted according to the drug product’s instructions for use. Once reconstituted, the drug product would be transferred to the enFuse using the appropriate system. The ST system is used for drugs reconstituted in a syringe, while the VT system is used for drugs reconstituted in a vial. No changes to the original container closure or additional preparation steps are required aside from insertion into the transfer device. Leveraging the enFuse system for delivery of SC lyophilised drugs offers several benefits, including ease-of-use, a hidden needle and hands-free delivery, designed to allow patients to perform light-to-moderate activities during injection.

 

THE FUTURE – THE ENFUSE DUAL VIAL TRANSFER SYSTEM

As more and more therapies move away from the clinic to lower cost sites of care (home infusion or self-administration), innovations in drug delivery need to incorporate designs that allow self-administration at home by the patient. The novel enFuse DVT system focuses on this for lyophilised drug products with large SC drug volumes. The enFuse DVT system is designed to provide a simpler solution to the reconstitution step, which is the largest source of error among patients self-administering lyophilised drugs. During the reconstitution step, patients are often confused by the number of steps and supplies, which contributes to instructions for use deviations and sterility breaches.

The enFuse DVT system is designed to simplify the process, such that the user feels comfortable preparing and administering their own therapies with confidence. The enFuse DVT system incorporates the same philosophy of administration as the enFuse VT system, but includes two vial insertion points. In the case of a lyophilised drug, one vial slot would include the lyophilised drug product and the other vial slot would include the diluent. Once filling is complete, the user removes the enFuse delivery device from the transfer base, places it on the abdomen and presses the button to begin SC delivery.

Lyophilised drugs require reconstitution at the time of use, adding additional preparation steps and complexity for the user; however, by using the enFuse DVT system, the process of reconstitution and administration can be simplified.

 

See the full article in ONdrugDelivery.

Introducing Enable Injections’ New Careers Site!

Here at Enable Injections, we are innovating the treatment experience – and expanding our team! A career with us is an opportunity to make an impact and create meaningful change both in a growing company and in the lives of patients.

Visit our new careers site to learn more about our collaborative, innovative culture, employee benefits, and view current open positions. Stay up to date on the latest openings by joining our talent community or connect with us via email at [email protected].

View our jobs and apply to join our mission today: https://enableinjections.com/careers/

Viridian Therapeutics Announces Partnership with Drug Delivery Innovator Enable Injections

Viridian Therapeutics Announces Partnership with Drug Delivery Innovator Enable Injections

– Partnership to support one of the Company’s preclinical programs outside of thyroid eye disease (TED) –

WALTHAM, Mass., May 08, 2023 (GLOBE NEWSWIRE) — Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced a new partnership with Enable Injections, a company developing and manufacturing the enFuse® innovative wearable drug delivery system for volumes of up to 25mL.

“As we expand our pipeline beyond TED and assess the unmet needs of patients living with other serious and rare diseases, it’s clear that convenient drug delivery is an important issue,” said Scott Myers, President and CEO of Viridian. “We believe Enable’s proprietary technology can contribute meaningfully to our goal of delivering therapeutic advances while reducing patient treatment burden as well.”

“Enable Injections is excited to partner with Viridian to utilize the enFuse® technology to enhance the patient experience,” said Michael D. Hooven, Enable Injections’ Chairman and CEO. “The enFuse® on-body delivery system was engineered with the patient in mind—the hidden needle and hands-free delivery allows patients to have increased flexibility, improved convenience, and the ability to administer medication discreetly, whether at home via self-administration or in the clinic.”

This partnership, which applies exclusively to areas outside of Viridian’s established TED portfolio, underscores the company’s commitment to patient-centric innovation.

About Viridian Therapeutics

Viridian Therapeutics is a biopharmaceutical company focused on engineering and developing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and engineering enables it to develop differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas.

Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The Company has initiated its first global Phase 3 trial called ‘THRIVE’ to evaluate the safety and efficacy of VRDN-001 in patients with active TED. Viridian is also evaluating VRDN-001 in a Phase 2 proof-of-concept trial in patients with chronic TED. In addition to its program for intravenously administered VRDN-001, the Company is advancing three candidates for its subcutaneous strategy with the goal of providing a more conveniently administered therapy to patients with TED. Viridian is also developing multiple preclinical assets in autoimmune and rare diseases.

Viridian is based in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and twitter.

About Enable Injections

Cincinnati-based Enable Injections is a global healthcare innovation company developing and manufacturing drug delivery systems designed to improve the patient experience. Enable’s body-worn enFuse® delivers high-volume pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. The investigational enFuse system has not been approved for use by any regulatory agency and is currently not approved for commercial use. For more information, please visit www.enableinjections.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or other similar terms or expressions that concern the Company’s expectations, plans and intentions. Forward-looking statements include, without limitation, statements regarding the Company’s expectations, strategies, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on the Company’s current beliefs, expectations, and assumptions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties, including our belief in the potential benefit of the Enable Injections technology and those risks set forth under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 9, 2023 and other subsequent disclosure documents filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither the Company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

Contacts

Investors:
Louisa Stone, 508-808-2400
Manager, Investor Relations
[email protected]

Todd James, 617-272-4691
Senior Vice President, Corporate Affairs and Investor Relations
[email protected]

Media:
Matt Fearer, 617-272-4605
Vice President, Corporate Communications
[email protected]

Source: Viridian Therapeutics, Inc.


View source version on GlobeNewswire.com

Sustainability Improvements in Drug Delivery with Allison Mack

The carbon footprint of an IV infusion may be more than you think. Hear more from Allison Mack, Medical Education Lead at Enable Injections, about the waste comparison of a standard IV and the enFuse systems in our latest #EnableWearableDelivery executive video series!

Transcript below:

Hi, my name is Allison Mack and I’m the nurse practitioner medical education lead here at enable injections today. I’m going to be talking to you about sustainability and IV waste comparison between IV infusions and our device.

So when people associate an IV infusion or IV equipment a lot of times they think well, I just need a basic bag of meds and a needle. Well, in fact, that’s not the case. You do need a lot more supplies when it comes to inserting an IV.

Here, we have the poll the bag the tubing and extension tubing and all of supplies here listed on or shown on the table. So you have your basic tape your syringe to flush lines. You have to have a barrier here to protect patient or the table that you’re going to be setting yourself up on you have your alcohol wipe shoot bandage and your tag Durham. This is all single-use equipment and it is set up for just one successful IV insertion.

We all know that IV’s never go in the first time easily. There are often multiple attempts and when that happens you actually need more equipment that’s listed here. You’re going to need a new needle you’re going to need more than one alcohol wipe and you’re definitely going to need more bandages.

Keep in mind as well with this equipment laid on the table. Every one of these items is single use so they come individually wrapped. So these are the bags here just to highlight some of the material that each and every single one of these come in they never come in as a kit.

So, what we have here too is a 3D model of some of the waste that’s laying on the table here tied to a bottle here. So, it just goes to show that putting an IV is just simply one needle in one bag. There’s a lot of other things that are involved going into an IV insertion and in infusion.

On the other side. We have our device the end views device. We have two devices here the gas file and the syringe instead of just one IV insertion kit. We actually have two devices here and you can clearly see we still have less equipment less waste than you do for a basic IV. We just have the devices the bases each every time you apply one of the devices you need a single-use alcohol wipe, you need your vial of medication and a syringe depending on the device that you use and each one comes in their carton. that houses the device this is resource none of this may or may not be used depending on where the device is actually placed if it’s placed in the home a lot of times the user the patient themselves may choose not to use gloves if it’s placed in a facility then they standard standardization is typically with gloves. So bottom line is IVs, although they may seem simple and produce less waste that’s not the case at all.

The enFuse® itself is clearly showing less wastage, and hopefully it’s a carbon footprint reduction.

The investigational Infuse system has not been approved for use by any regulatory agency and is currently not approved for commercial use to learn more about the Infuse. Please visit enable injections.com.