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Hera Health Solutions

Proprietary biodegradable drug delivery implants

Security Offered

Preferred Shares

Minimum Investment: $100

  • Full utility patent filed in July 2018, and a trial batch has been created with Nanofiber solutions

  • Won $10,000 prize at the Get Started Louisiana Pitch Nighti

  • A Zeroto510 med-tech accelerator portfolio company; received $100,000 in seed funding

  • A BioExel med-tech accelerator portfolio company; received €95,000 (~$105,000) in seed fundingii

Executive Snapshot

Hera Health Solutions is a pharmaceutical device company based in Memphis, Tennessee. It specializes in the research and development (R&D) of long acting treatments through subcutaneous—under the skin—biodegradable drug delivery implants. A full utility patent has been filed on its proprietary technology, that aims to eliminate painful, costly, and risky implant removal procedures by introducing a biodegradable material that resorbs into the body as the drug or hormone of choice is released. Bench studies have already been completed, and a preliminary protoype of the company’s first product, Eucontra, has been produced with its manufacturing associate Nanafiber Solutions. The executive team is now prepping for the Food and Drug Administration (FDA) and World Health Organization (WHO) approval processes, and an international market launch. However, Eucontra is just the first of many biodegradable implantable products Hera Health seeks to create for the growing drug-delivery market. The company also aims to provide different solutions to the veterinary, opioid-addiction, hormone therapy, and breast cancer markets in the future.

The executive team has taken the company through the Zeroto510 medical technology accelerator program in Memphis, Tennessee, and has a signed commitment from an early-stage healthcare venture capital firm—Innova Memphis—to lead the round. Innova has agreed to fund one third of the total $1.25 million raise. Since inception, Hera Health has raised $100,000 from investors in the U.S. and €95,000 (~$105,000) from a med-tech accelerator program in Ireland. The company hopes to achieve market approval in late 2020, and launch domestically and abroad by April 2021.

Terms

Investment Terms

Security Type: Series Seed Preferred Shares

Round Size: Min: $25,000 Max: $107,000

Price Per Share: $5.00

Valuation: $4,200,000

Liquidation Preference: 1x

Conversion Provisions: Convertible into one share of Common (subject to proportional adjustments for stock splits) at any time at the option of the holder.

Overview

Opportunity

In 2017, 55% of Americans were reported to take at least one prescription medication daily.iii In today’s healthcare environment, administering quality medication can be troublesome for those who need a continual and constant medication dosage over prolonged periods of time. According to the FDA, many medications are not taken as prescribed 50% of the time. Further, 20% to 30% of new prescriptions are never even filled at the pharmacy. The FDA cites failure to understand directions and forgetfulness are some of the primary reasons patients don’t follow their medication regimens.iv

One alternative to replace a daily pill regimen is an under-the-skin implant that provides a continual dose of medication for long periods of time. The Nexplanon contraceptive sub-dermal implant by Merck is a good example of this.v These implants offer an alternative solution for the issues related to long-term therapies and strict pill regimens. Unfortunately, once the lifespan of an implant is exhausted and the drug is completely consumed, the implant must be removed via a potentially painful and/or expensive surgical procedure. These procedures have left some patients with heavy bruising and scarring and may even require a visit to the operating room to remove migrated or lost implants if they were dislodged and traveled to another part of the body. As a result, thousands of patients have filed adverse reports against the product with the FDA. At least 400 of those reports were classified as a “device dislocation,” and 100 were regarded as “serious” by the FDA.vi

The idea for Hera Health and Eucontra started as a biomedical engineering capstone project at Georgia Tech, where bioengineering students were given a task to locate and remove lost implants in a patient’s arm. Along the way, the Hera Health team developed a technology that would eliminate this problem from ever occurring in the first place. Now, the company’s goal is to provide a drug delivery implant that could change the way people take regimented medication all over the world.

Founded in 2017, Hera Health Solutions is developing an innovative biodegradable drug delivery implant that seeks to revolutionize the long-acting drug delivery process. Its patent-pending technology aims to eliminate the need for painful, costly, and risky implant removal procedures by introducing a biodegradable material that resorbs into the body as the drug or hormone of choice is released.

Press

Product

Hera Health’s first product, Eucontra, is a long-acting biodegradable contraceptive implant that’s intended to prevent pregnancy for up to 12 or 16 months.

The Eucontra implant has been prototyped, and its bench studies have been completed. It’s now currently undergoing tests to meet the FDA and WHO preapproval criteria, which the company hopes will be granted late in 2020 and early in 2021, respectively. If approved for public use, Eucontra could provide more women access to a less invasive long-acting contraceptive by removing the fear of painful and costly removal procedures. The company intends to sell Eucontra to OB/GYNs and family planning clinics. From there, healthcare professionals trained in the insertion of subdermal implants can administer Eucontra to their patients.

Hera Health has filed a full utility patent on its technology with a priority date of July 8th, 2017, and all rights have been assigned to the founders. The company intends to submit an Investigational New Drug Application (IND) for Eucontra with the FDA through the 505(b)(2) pathway. The 505(b)(2) pathway is an expedited hybrid approval process for drugs or devices that are similar to current products already approved by the FDA. It allows drug companies to use research data from similar already approved products and helps alleviate the burden of duplicating time consuming and costly studies.

The WHO approaches medical device approvals in a similar fashion as the FDA, but on a case by case basis. However, inspections carried out by stringent regulatory agencies, like the FDA, are recognized by the WHO, so any previous work generated in a prior approval process will not need to be duplicated.vii If a product is found to meet the WHO’s requirements and complies with good manufacturing processes (GMP), the product, manufacturing site, and company will be added to the WHO’s prequalified list of medical devices.viii Hera Health intends to use the research generated during its FDA approval process to apply for acceptance to the WHO’s list of prequalified medical devices once FDA approval is granted.

Preliminary batches of Eucontra have already been created with the manufacturer Nanofiber Solutions. The manufacture and its factory are currently classified as a good manufacturing process (GMP) facility, and it’s anticipated that Nanofiber Solutions will produce Eucontra at scale, once FDA and WHO approval has been granted.

Use of Proceeds

Hera Health intends to use proceeds from the raise to pay for the costs connected with the FDA 505(b)(2) approval process, and the WHO’s pre-approval process. If Hera Health raises the maximum amount of $107,000, it plans to use the proceeds primarily for research and development (25%), general working capital (15%), regulatory development (25%), manufacturing (5%), and future wages for additional team members (30%). If Hera Health raises the minimum amount of $25,000 it plans to use the proceeds primarily for research and development (50%) and future wages (50%).

Product Roadmap

Currently, the company aims to finish its pre-clinical trials by September 2019, its clinical trials by November 2020, and obtain final FDA and WHO approval by December 2020 or early 2021. It hopes to commence its market launch by April 2021 and begin distributing Eucontra to OB/GYN medical providers.

To achieve these milestones, the company plans to hire a consulting group to help facilitate and complete the FDA approval process. It also plans to hire individuals for the following roles to help advance Eucontra toward the final stages of market distribution:

  • R&D specialist
  • FDA regulatory expert
  • Sales and marketing team
  • Medical device manufacturing expert

Marketing and Promotion

Hera Health aims to spread awareness for Eucontra mainly through partnerships and sponsorships within the OB/GYN and family planning spaces, as well as with global humanitarian organizations and healthcare distributors who focus on areas related to family planning and women’s health. If the product—Eucontra—is approved for use, the company also plans to launch an extensive commercial marketing campaign involving sales representatives and media advertisement. The company’s domestic growth plan also heavily involves broadening professionals’ knowledge of its technology through trade shows and conferences.

The company aims to gain endorsements for its technology through networking, and has already mapped out potential conferences to attend across the U.S. It seeks to connect with key opinion leaders on a national level and hopes to keep these connections engaged as the company continues to develop Eucontra and fulfill the necessary regulatory requirements for FDA and WHO approval.

Business Model

Hera Health intends to sell to OB/GYN practices as well as family planning clinics in the U.S. market. It also intends to price Eucontra at $800 per device, which the company believes is competitive with its alternative, Nexplanon. In the U.S., Hera Health hopes that Eucontra will be reimbursable through insurance, which could lower the price point for consumers. The reimbursement code for contraceptive arm implants utilizing a generic contraceptive drug already exists, as well as the code for under the skin implant insertion.ix

The executive team estimates a 98.5% gross margin for retail sales but intends to heavily subsidize Eucontra for bulk distribution to international humanitarian partners.

Internationally, the company will seek to sell to nonprofit organizations and large-scale Non-Governmental Organizations (NGOs) that distribute contraceptives to countries with limited access to healthcare. While it may be a prevalent option for women in the U.S., from a global perspective, many women, particularly in developing countries, may have limited options or access to contraception. The WHO reports that 214 million women in developing countries—who want to avoid pregnancy—are not using a modern method of contraception. Some women in these areas fear side effects, while others are afraid to be associated with the cultural and/or religious taboos related to contraception, among other factors.x

Traction

Investor Traction

In May 2018, Hera Health raised $100,000 from the venture capital firms Innova Memphis and MidSouth Sustainable Energy solutions. Additionally, in November 2018, the company raised €95,000 (~$105,000) from the international med-tech accelerator fund BioExel. BioExel’s accelerator program aims to boost the med tech startup ecosystem in Ireland and attract global talent. It’s backed by Enterprise Ireland, the Western Development Commission (WDC), the Galway University Foundation, and the Bank of Ireland Seed and Early Stage Equity Fund.  Hera Health is one of BioExel’s first American portfolio companies, and through this partnership, it has received access to worldwide partnership organizations, EU regulatory landscape consultants, and a working lab and office space.

Pitch Competitions

Hera Health has won multiple awards at pitch competitions across the world and has presented its product at events sponsored by Cox Media, South by South West (SXSW), and more. Competition judges include individuals such as Revolution’s Partner Todd Klein, Backstage Capital’s Principal Lolita Tub, and Black Girls Code CEO Kimberly Bryant. Events the company has participated in include:

Date

June 2019

March 2019

November 2018

April 2017

Award

Healthcare participant

Finalist

$10,000 prize winner

Named top emerging medical device innovation

Competition

Global Entrepreneurship Summit

SXSW Startup of the Year Competition

Get Started Louisiana Pitch Nightxii

International Design of Medical Device Competitionxiii

The company will also participate in the 2019 Global Entrepreneurship Summit (GES) sponsored by the U.S. State Department and the Netherlands’ Ministry of Foreign Affairs.xiv The summit will bring together 2000 global leaders in entrepreneurship, innovation, investments, and policy to turn world challenges into business opportunities.xv

Startup Accelerators

Hera Health has won multiple awards at pitch competitions across the world and has presented its product at events sponsored by Cox Media, South by South West (SXSW), and more. Competition judges include individuals such as Revolution’s Partner Todd Klein, Backstage Capital’s Principal Lolita Tub, and Black Girls Code CEO Kimberly Bryant. Events the company has participated in include:

Date

November 2018

May 2018

May 2017

Accomplishment

Gained access to EU regulatory consultants

Finalized regulatory testing plan

Completed the first prototype

Venue

BioExel International Med-tech Accelerator Programxvi

ZeroTo510 Medical Device Accelerator Programxvii

Georgia Tech I2P Programxvii

Business affiliates include Innova Memphis, the ZeroTo510 accelerator program, American Preclinical Services, StartCo Memphis, BioExel, the Georgia Tech Institute of Technology, fhi360, Charles River, and Nanofiber solutions.

Historical Financials

Hera Health Solutions did not generate any income in 2017. Although the company was incorporated in June of 2017, actual operations did not commence in full force until January of 2018. Incorporating was done mostly to aid the founders in filling for IP patents. In 2018, the company generated $32,700, $20,000 of which came from grants, and $12,700 came from pitch competition winnings. In 2019, the company received $2,000 in pitch competition winnings and has generated a total of $34,700 in revenue since inception.

In 2018, expenses totaled $121,742, $50,000 of which was spent on accelerator tuition in May. Rent for office and lab space, and prototyping and testing were the next highest expenses at $16,796 and $14,905, respectively. Since inception and through February 2019, operating expenses have totaled $130,586. Expenses spiked in May 2018, due to the one-time accelerator tuition payment, and in June 2018 due to an IP patent fee of $5,000.

As mentioned earlier, Hera Health began as a university capstone project at Georgia Tech. Although the company was incorporated in June of 2017, actual operations did not begin until January 2018. The reason for incorporating in 2017 was to aid the founders in filing for IP patents. As such, there was no income, net or otherwise, in 2017. In 2018, Hera Health Solutions generated a net loss of $89,042, and in 2019, the company has generated a net loss of $6,375 as of February. Since inception and through February 2019, the company has generated a net loss of $95,886. In 2018, the company’s average monthly burn rate was $10,145, based on its operating expenses. Excluding the one-time accelerator payment, Hera Health’s average monthly burn rate was $5,979 for 2018. As of February 2019, the company had $83,854 in cash. The company anticipates 12 to 14 months’ worth of runway with its current cash position.

Industry

In 2016, the global market for contraceptives was valued at over $22.1 billion and is forecasted to grow at a compound annual growth rate (CAGR) of 6.1% from 2017 to reach $37.2 billion in 2025.xix Awareness campaigns about STDs, and the relative ease of availability for contraceptive devices are anticipated to propel demand over the forecast period. Over the past 10 years, key market participants have aligned their marketing strategy with a more informative type of campaign in order to establish a regular customer base, and it’s suspected that alliances between contraceptive market participants of all sizes will become a common trend in the global market for years to come.xx    

In the U.S., the contraceptive market was valued at an estimated $7.6 billion in 2017,xxi and it’s forecasted to grow at a CAGR of 5.3% to reach $11.6 billion by 2025.xxii Also, according to Grand View Research, the introduction of new products is anticipated to help drive market growth. In particular, the subdermal implant is projected to be the fastest growing segment between 2018 and 2025, as companies are promoting its high success rate and its ability to provide long-term protection. Additionally, the U.S. government, which has historically been one of the largest donors to family planning and reproductive health (FP/RH) programs, could further boost demand through additional initiatives that promote the use of contraceptives.xxiii

IUD use among women in the U.S. between the ages of 30 to 34 years old is anticipated to grow at CAGR of 7.7% from 2018 to exceed $2 billion by 2024.xxiv According to Boston University, the demand for long acting removable contraceptives—like arm implants and intrauterine devices (IUDs)—have been on the rise since 2016. Changes in governmental regulations like funding cuts for Planned Parenthood and the Affordable Care Act are suspected to be the underling factors in the occurrence of this trend.xxv

According to Market Research Engine, the implantable drug delivery devices market—which includes the implantable contraceptive market—is expected to grow at a CAGR of 8.5% and exceed $34 billion by 2024.xxvi Implantable drug delivery devices have many applications, including diabetes management, contraception, HIV/AIDS prevention, chronic pain management, cardiology, oncology, and central nervous system health. These devices can be implanted under the skin (subcutaneously), and in other areas via intravaginal, intravascular, intraocular, intrathecal, and peritoneal. Also, drug eluting devices can be separated into two categories, biodegradable and non-biodegradable. Biodegradable implants deliver drugs and decompose overtime. They are made from materials such as polyester amide (PEA), and polylactic-co-glycolic acid (PLGA). Their counter parts, non-biodegradable implants are made from materials such as silicone rubber, polyethylene-vinyl acetate (EVA), and thermoplastic polyurethane (TPU). These non-biodegradable devices generally cost less and can be designed to deliver drugs in many ways, including a matrix, reservoir, or via osmosis. Some can even be refilled with medication and can be removed to discontinue the release of medication almost immediately.xxvii

In 2018, capital investments in the drug delivery market totaled $2.27 billion across 145 deals. This represents a 67.2% year-over-year increase in capital invested and a 23.7% year-over-year decrease in the number of deals completed. 2018 was highlighted by a $350 million Series C round for Rakuten Medical, which is a developer of precision-targeted cancer therapies. Over the past 11 years, about $14 billion has been invested across 1,635 deals.xxviii

Competitors

Merck (NYSE:MRK)

In 2011, Merck announced the release of Nexplanon, its long-lasting single rod hormonal contraceptive implant that would be available in the U.S. and Canada. The device was shown to be 99% effective and was approved by the FDA for the prevention of pregnancy in women for up to three years.xxix Removal of the implant involves a surgical procedure that can be performed by a trained professional at any time during the three-year period.xxx To perform the procedure, a health care provider will need to make an incision in the arm where the implant is located, and remove the device with forceps or some other clamping device. Retail pricing for Nexplanon ranges from $938 to $985 dependent upon the provider.xxxi Merck is a global healthcare pharmaceutical company and operates in 140 countries. It provides innovative health solutions, prescription medicines, vaccines, biologic therapies, consumer care, and animal health products.xxxii

The Bayer Group (OTC: BAYRY)

Mirena is an intrauterine device (IUD) placed in the uterus to provide continuous birth control. It’s 99% effective and can prevent pregnancy for up to five years. This IUD is also approved by the FDA to treat heavy periods—also known as heavy menstrual bleeding.xxxiii Retail pricing for Mirena ranges from $1,005 to $1,055 dependent upon the provider.xxxiv Skyla is an IUD placed in the uterus to provide continuous birth control. The implantation process is non-surgical and can be performed by a healthcare provider during a routine visit. The device is 99% effective at preventing pregnancy and can be removed by a healthcare provider at any time. This IUD is FDA approved and can be used even if a woman has previously given birth to a child.xxxv Retail pricing for Skyla ranges from $837 to $879 dependent upon the provider.xxxvi Mirena and Skyla are both manufactured by Bayer, a German multinational life science and pharmaceutical company. In 2018, Bayer was comprised of 420 consolidated companies in 90 countries across the world.xxxvii

Allergan (NYSE: AGN)

Liletta is an IUD made of flexible plastic that contains a hormone called levonorgestrel, which is slowly released once inserted in the uterus. It’s capable of preventing pregnancy for up to five years and can be removed by a healthcare professional at any time.xxxviii The Liletta hormone releasing system was approved by the FDA in February 2015,xxxix and is manufactured by Odyssea Pharma SPRL—an Allergan affiliate. Allergan offers the LILETTA Patient Savings Program to help eligible patients with out-of-pocket costs. Eligible patients can pay as little as $100, and save up to a maximum of $700, for the product.xl Allergen has partnered with Medicines360—a nonprofit women’s health pharmaceutical company—to make Liletta available to areas affected by the Zika virus.xli

Cooper Surgical, Inc

Paragard is a small t-shaped, hormone-free IUD made of soft flexible plastic wrapped with a thin layer of copper. It can prevent pregnancy for up to 10 years and was found to be 99% effective. Paragard relies on one active ingredient—copper—so it is hormone-free and can provide pregnancy prevention without unwanted hormonal side effects. The implantation process can be performed by a healthcare professional during regular office visit and lasts only a few minutes.xlii The full price of ParaGard can range from $500 to $739.xliii In November 2017, Cooper Surgical acquired ParaGuard from Teva Pharmaceuticals for $1.1 billion in cash.xliv

Team

Executive Team

Idicula Mathew

Co-founder and CEO

Idicula co-founded Hera Health Solutions and has been CEO since its inception. He has a background in product development with a concentration in biotechnology research, and he has prior startup experience. At Hera Health Solutions, Idicula provides vision, leads business development, intellectual property management, and commercialization. Idicula has a bachelor’s degree in biomedical engineering from the Georgia Institute of Technology.

Garrett Whitfield

Co-founder and COO

Garrett co-founded Hera Health Solutions and has a background in prototyping and manufacturing medical device technology. He has worked together with Idicula since Eucontra’s idea creation phase in early 2016. Garrett leads the company’s internal processes, human resources, and quality management. He holds a bachelor’s degree in biomedical engineering from the Georgia Institute of Technology.

Advisory Team

Dr. Blair Brettmann

Technical Advisor

Dr. Brettmann is an electrospinning and drug delivery pioneer. She is an assistant professor at the Georgia Institute of Technology and was a postdoctoral researcher at the University of Chicago’s Institute for Molecular Engineering. She has a bachelor’s degree in chemical engineering from the University of Texas, and a PhD in chemical engineering from the Massachusetts Institute of Technology (MIT).xlv

Richard Dimonda

Corporate Advisor

Richard is a medical device regulatory and market specialist who specializes in helping entrepreneurial startups. He is trained in electrical and biomedical engineering and has many years of medical device commercialization experience from a variety of public and private companies. He has executive management and hands-on experience with premarket approval (PMA) with the FDA, and the 510k clearance process. So far, he’s managed five PMA clinical trials, and has worked in over 18 different fields of medicine. He uses his knowledge to help companies refine their value proposition and product to be in alignment with health care policy initiatives to secure third party reimbursement.xlvi

Chris West

Commercial Advisor

Chris West is the president of the ZeroTo510 accelerator program and a pharmaceutical commercialization expert. He assists the accelerator’s portfolio companies with go to market plans, and he executes the program’s vision to assist with a broader range of medical device entrepreneurs in various stages of development. Chris is a former executive in the pharmaceutical and biotech Industry with more than 20 years of experience in sales force leadership, as well as tactical and strategic marketing on industry-leading Brands such as Advair, Valtrex, and Avodart. He has a bachelor’s degree from the United States Military Academy at West Point, and an MBA from Duke University.xlvii

Past Financing

Discussion

Endnotes

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