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HB Biotechnologies Corporation provides a clinically proven and transformative approach to fluid management, and changes the paradigm of how fluid is managed by and eliminated from the body.
Our mission is to provide millions of people with a safe and effective, low risk tool so that they may experience dramatic and beneficial quality of life improvements that are not achieved by other strategies.
With this offering, we aim to create a community of people and a legion of angels who are eager, excited, and enthusiastic about joining us in this journey to do something transformative and help patients worldwide who are suffering from heart failure and chronic kidney disease.
Your kidneys keep the fluid in your body in balance, When kidney function begins to fail in heart failure and chronic kidney disease patients, fluid that the patient would normally process and excrete through urination, has nowhere to go, so it begins to build up in the body.
When this fluid buildup accumulates in the body, it causes the condition known as fluid overload. This condition makes the heart work harder, which causes heart failure that could have otherwise been avoided and ultimately leads to death.
Now with Fluid Lock System, healthcare practitioners will be able to prescribe a clinically proven and patented tool that absorbs fluid from the body and delivers significant improvements in the signs and symptoms of fluid overload.
Clinically meaningful results have been shown in edema; blood pressure; endurance; breathing ability; weight; and, most consequentially, heart failure classification.
Even a moderate penetration of the market can result in exponential product adoption by millions of willing patients.
Over $265 billion in global markets that address the management of excess fluid in the body.
Global patient population for congestive heart failure and chronic kidney disease is over 110 million people. In the United States alone, there are 39 million people with chronic kidney disease, half a million people with end stage renal disease on hemodialysis, and over 6.2 million people with congestive heart failure.
Total addressable market for this low risk tool to help heart failure and chronic kidney disease patients manage their fluid could reach in excess of $50 billion annually.
Fluid Lock System is an encapsulated superabsorbent polymer that can help prevent disease progression and keep conditions from worsening by transforming fluid into a gel that is eliminated from the body via the gastrointestinal route -- bypassing the kidneys.
Each grain of the dry superabsorbent polymer material is comprised of a porous network. Fluid is absorbed into the pores of the polymer and becomes entrapped.
The stomach is a biological filter that draws in gastric juice components from the circulatory system -- a vascular network that circulates blood throughout the body.
The gastric juice components that were filtered out of the circulatory system and into the stomach are reabsorbed into the circulatory system through the intestines.
In heart and kidney failure, this recycling effect causes fluid to accumulate because the fluid is not able to naturally leave the body in its entirety either through feces or urine.
Fluid Lock System provides a low risk tool that is intended to absorb fluid from the circulation via the gastrointestinal route and can help keep fluid overload from occurring.
Patent granted in Japan in December 2018.
Patent granted in all 38 member states of the European Patent Organization in July 2019, including: Albania, Austria, Belgium, Bulgariam Croatia, Cypress, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Macedonia, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Romania, San Marino, Serbia, Slovenia, Spain, Sweden, Switzerland, Turkey.
Patent granted in Canada in November 2019.
Patent pending in the United States. Big news expected in 2022.
Patented claims include: an orally consumable product comprised of a hydrophilic fiber, powder, gel, or grain for use including but not limited to:- in treating renal failure;- reducing the frequency of dialysis;- treating obesity;- inducing a sense of fullness;- removing excess accumulation of serum toxins;- treating hyperkalemia;- treating hyperammonemia;- treating uremia;- relieving constipation;- reducing triglycerides;- treating non-insulin dependent diabetes.
The use of superabsorbent polymer technology in the gastrointestinal tract is a novel solution to help alleviate excess fluid in the circulation, independently of kidney function.
Data shows that use of the device results in consistent positive effects on indicators associated with fluid overload. These effects resulted in a pattern of improvements over placebo in both physician-assessed and patient-reported outcomes.
Improvements in patient health -- including measures of fluid overload, quality of life, and functional capacity -- support that the device is effective for its intended purpose of fluid management.
A low-risk strategy with potential as a first-in-line standard of care to help manage fluid overload could help lessen the likelihood of hospitalizations, help mitigate the signs and symptoms of fluid overload, and help improve causal conditions.
Patients experienced clinically meaningful improvements in the signs and symptoms of fluid overload, including but not limited to:- Dyspnea as measured by the Likert scale, which assesses the degree of pulmonary congestion.- Peripheral edema.- Pulmonary rales.- Change in body weight from baseline.- Reductions in blood pressure in patients with baseline systolic BP >130 mmHg- Electrolyte balance, including sodium and potassium.- Clinical summary scores on the Kansas City Cardiomyopathy Questionnaire (KCCQ) which measures the patient's perception of their health status, including heart faillure symptoms; impact on physical and social function; and how their heart failure impacts their quality of life (QOL).- Proportion of subjeçts with NT-proBNP <1000 pg/mL -- an indicator for the diagnosis of heart failure.- Stage of heart failure -- New York Heart Asociation (NYHA) Functional Classification
We strive to make Fluid Lock System a trusted household name for families in need. We are commited to providing a superior medical product with a proven safety and effectiveness profile.
HB Biotech recently celebrated a massive milestone and major win with the formation of key manufacturing partnerships that will foster the global success of Fluid Lock System. These significant manufacturing partnerships with industry titans to produce the commercial product provides the scale and infrastructure necessary for the sustained growth of our global brand.Evonik is a top three global manufacturer of superabsorbent polymer material and a $14 billion dollar company. Evonik is committed to being the long-term supply partner for HB Biotech's proprietary, innovative polymer. Evonik Biomaterials and Evonik Oral Drug Delivery Solutions will leverage their core competencies to manufacture the medical device material. Compliant with GMP, ISO, and QMS regulations and meets all global regulatory compliance and conformity mandates.Patheon is the $7 billion dollar manufacturing arm of Thermo Fisher Scientificm a $20+ billion Fortune 500 Company. As a leading CDMO, Patheon is GMP, ISO, and QMS compliant. Patheon has committed to provide HB Biotech with a fully integrated global network of facilities to encapsulate, package, and prepare Fluid Lock System for commercial distribution. Led by Anil Kane, Ph.D., MBA, Executive Director and Global Head of Technical and Scientific Affairs for Thermo Fisher Scientific.In our journey to commercialization, HB Biotech is also working with instrumental partners to help us shepherd Fluid Lock System through various regulatory processes.Emergo is a globally respected regulatory consultant and trusted authority in the medical device industry. Emergo is working with HB Biotech to provide regulatory assurance for CE certification in the European Economic Community, regulatory clearance in Japan, and medical device license in Canada.DuVal & Associates is a critical partner for the the prosecution of HB Biotech's 510(k) submission for United States FDA medical device regulatory clearance. Led by Mark DuVal, J.D., former chairman of the Food, Drug, and Medical Device Section of the Minnesota State Bar Association.REGULATORY CLEARANCE = GAME CHANGER
Superabsorbent polymer technology for use in the gastrointestinal tract is a burgeoning industry that is primed for commercialization -- with over a billion dollars invested in clinical studies that support safety and effectiveness. There is no direct competition for Fluid Lock System and its intended use in the cardio renal space as a tool for fluid management; and HB Biotech maintains patented competitive advantages.
Gelesis. Gelesis' product Plenity was cleared as a medical device for weight management and obesity by the US FDA in 2019, and received the CE mark as a medical device in the European Economic Area in 2020. Completed a $425+ million licensing deal with China in 2020, and launched an IPO through an SPAC in 2021 and was valued as a $1.5 billion company. Interestingly, Gelesis provides HB Biotech with a substantially equivalent predicate device in the US and European Economic Community for regulatory clearance for Fluid Lock System.
Sigrid Therapeutics. A direct competitor to Gelesis, Sigrid Therapeutics focuses on the development of the non-absorbed polymer as a medical device for lowering blood sugar in prediabetes and obese patients. Patients pour the dry polymer into water and ingest a prehydrated gel that occupies stomach volume. Sigrid has raised over $12 million in venture financing and grants for ongoing clinical studies since 2019.
Epitomee by Nestle Health Science. Another direct competitor to Gelesis in the obesity space, Epitomee is currently conducting clinical studies and relies on Gelesis as a predicate device. The hydrogel film strip is rolled up and encapsulated, and then unfurls in the stomach, occupying stomach volume. In a 2020 licensing agreement, Epitomee granted Nestle Health Science exclusive and global commercial rights to use, market, launch, and sell the product.
Tricida. Focused on cliniçal development in the drug pathway, the orally administered polymer is intended to treat metabolic acidosis in patients with chronic kidney disease. The pore size of the polymer grain can be engineered larger or smaller to absorb molecules of varying sizes. Currently in Phase III clinical trials. Series D in 2015 for $257 million. IPO in 2019 with $4450 million.
Relypsa. Veltassa by Relypsa was approved by the US FDA in 2015 as non-absorbed drug to treat hyperkalemia -- high potassium levels in the blood. Patients pour the dry polymer into water and ingest a prehydrated gel that helps the body get rid of excess potassium through the stool. Relypsa was acquired in 2016 for $1.5 billion. Sales in 2020 were $127+ million. Most recently, the corporate valuation for Relypsa was $3.2 billion.
Fluid Lock System by HB Biotech is a renal device that is intended as a tool to absorb fluid from the circulation via the gastrointestinal route, and marks a significant advancement in cardio renal specialty care. With over $150 million in clinical studies that support safety and effectiveness, patents in forty countries which guarantee market exclusivity, and manufacturing capabilities that meet the scale of a blockbuster already in place, HB Biotech will be using this round of funding to secure medical device regulatory clearance and CE certification.
While Fluid Lock System is regulated as a medical device, it follows the same revenue model as a pharmaceutical drug. Fluid Lock System is sold as a standard, uniform unit consisting of 320 devices per carton. The product is expected to be covered by insurance and included in the formulary as a prescription medical device. There is ample justification for insurance coverage, and the product already falls under existing coding for coverage.
When Fluid Lock System becomes the household name that we have designed it to be, potential gross revenue is off-the-charts astronomical and almost too hard to believe. For example, if 5% of the total patient population (approximately 5.5 million people) used eight devices per day over the course of six months during a one year period, gross revenue would be in the range of $40 billion dollars -- conservatively.
Future expected expenses in order to attain this level of success include: commercial manufacturing prep; procurement of technical documentation; regulatory activities; inventory ramp up for commercial production and sales; launch activities; marketing; distribution; retail pharmacy rebates; etc.
We encourage you to run the numbers and measure our potential revenue for yourself. It's a fun exercise, and you will be able to easily see why investing in HB Biotech makes sense. It's a meaningful and satisfying investment on many levels.
Currently HB Biotech is raising capital to attain a singular milestone: MEDICAL DEVICE REGULATORY CLEARANCE -- a game changer in the lifecycle of our business. Clearance allows us to market and sell the product.
The regulatory process for securing medical device clearance varies by region, but in general, takes anywhere from one to six months to complete.
Each clearance HB Biotech receives further skyrockets the value of our business and our stock.
In order to be in the position to submit our regulatory applications,, HB Biotech needs to:
- Create a fully finished commercial batch of Fluid Lock System.- Prepare final technical files and documentation for regulatory submissions.We will be using the capital we raise through equity crowdfunding to complete these activities and undertake regulatory clearance activities. Additionally, we will use proceeds to:- Undertake all regulatory processes with the US FDA and global regulatory agencies to obtain US device clearance and CE certification.- Initiate dialog with distributors, pharmacy benefit benefit managers, CMS and other insurance reimbursement, retail networks, and other agencies and outlets to facilitate market penetration.- Support preparations for commercial stage manufacturing and product launch.- Manage other functions associated with the operation of the business.
Disclaimers: Contains forward looking statements. Product statements not yet evaluated by regulatory authorities. Forward looking financial statements. Actual product adoption, sales, revenue, growth, expenses, margins, and profit may vary higher or lower than projected. No revenues are guaranteed.