Friday, October 19, 2018

UPDATE: Nephros Announces Preliminary Financial Results for Third Quarter 2018

Source:  Nephros, Inc.-October 1, 2018

Anticipates 102% Year-over-Year Product Revenue Growth;
Reiterates $6 Million 2018 Revenue Target

Nephros, Inc. (OTCQB: NEPH), a commercial stage medical device company that develops and sells high performance liquid purification ultrafilters, today announced preliminary financial results for the third quarter of 2018.

Nephros expects product revenue for the quarter to be approximately $1.7 million,which represents a 102% increase over the same period in 2017.

“There has been a dramatic increase in the awareness of water safety over the last few years,” said Daron Evans, President and Chief Executive Officer. “Our focus on consultation and rapid responsiveness enables our customers to achieve measurable performance improvement from our products. Our continued revenue growth is a result of our expanded product line based on customer feedback as well as a multi-year campaign of education and customer support.”

“In our upcoming 10-Q filing, we intend to report results from our water filtration business both separately and consolidated with our Specialty Renal Products (SRP) subsidiary,” said Andy Astor, Chief Financial Officer. “This will provide our shareholders with greater transparency for each respective business unit, including the company’s progress towards profitability in the water filtration business.”

Nephros ended the quarter with approximately $5.2 million in cash on a consolidated basis.

About Nephros, Inc.
Nephros is a commercial stage medical device company that develops and sells high performance liquid purification filters, known as ultrafilters. Nephros ultrafilters are primarily used in hospitals and medical clinics for added protection in retaining bacteria (e.g., Legionella, Pseudomonas), viruses, and endotoxins from water. They provide barriers that assist in improving infection control in showers, sinks, and ice machines. Additionally, Nephros ultrafilters are used by dialysis centers for assisting in the added removal of biological contaminants from the water and bicarbonate concentrate supplied to hemodialysis machines and the patients.

For more information about Nephros, please visit the company’s website at www.nephros.com. 

About Specialty Renal Products, Inc. 
Specialty Renal Products, a subsidiary of Nephros, is focused on the development of medical device products for patients with renal disease, including a hemodiafiltration system for the treatment of patients with ESRD.


Thursday, October 18, 2018

Specialty Renal Products Announces $3 Million Series A Financing

Source:  Nephros, Inc.-September 6, 2018

Specialty Renal Products, Inc. (SRP), a private medical device company focused on the development of products for patients with renal disease, including a hemodiafiltration (HDF) system for the treatment of patients with End Stage Renal Disease (ESRD), and a subsidiary of Nephros, Inc. (OTCQB: NEPH), announced today that is has closed a $3 million Series A financing.

SRP intends to use the proceeds from the financing to complete development of its second-generation HDF system, with a planned initial launch in late 2019.  The company’s first-generation device is currently the only FDA-cleared HDF system in the United States.

“This financing significantly bolsters the next phase of the HDF story,” said Daron Evans, President and CEO of SRP. “We expect this round to fund the development and initial commercial production of SRP’s second-generation HDF system, as well as its initial launch into the market.”

The financing was led by Wexford Capital and Arbor Capital, and included participation by the management of SRP. Following the financing, Nephros will retain a 62.5% equity interest in SRP.

About Specialty Renal Products, Inc.
Specialty Renal Products, a subsidiary of Nephros, is focused on the development of medical device products for patients with renal disease, including a hemodiafiltration system for the treatment of patients with ESRD.

About Nephros, Inc.
Nephros is a commercial stage medical device company that develops and sells high performance liquid purification filters. Nephros filters – known as ultrafilters – are used primarily in medical applications in various settings. These ultrafilters are used by dialysis centers for assisting in the added removal of biological contaminants from the water and bicarbonate concentrate supplied to hemodialysis machines and the patients. Additionally, Nephros ultrafilters are used in hospitals and medical clinics for added protection in retaining bacteria (e.g., Legionella, Pseudomonas), viruses and endotoxins from water. These ultrafilters provide barriers that assist in improving infection control in showers, sinks, and ice machines.

For more information about Nephros, please visit its website at www.nephros.com.

Nephros Subsidiary Specialty Renal Products and HemoCleanse Announce License Agreement for Dialysate Filtration System

Source:  Nephros, Inc.-August 14, 2018

Pioneering HemoCleanse CEO to Join Specialty Renal Products Board of Directors

Specialty Renal Products, Inc. (SRP), a subsidiary of Nephros, Inc. (OTCQB:NEPH), a medical device company that develops and sells a hemodiafiltration system for the treatment of patients with End Stage Renal Disease (ESRD), and HemoCleanse Technologies, LLC, (HCT) a medical device company focused on the development of sorbent products to improve outcomes for patients on hemodialysis (HD), announced today that they have entered into an exclusive agreement to develop and commercialize a dialysate regeneration and filtration system.

Under the agreement, SRP has obtained the worldwide development and commercialization rights to patents, know-how and improvements relating to carbon-based sorbent technology intended for use in the field of the treatment of renal disease. HCT retains the commercialization rights to the carbon-based sorbent technology in fields outside of the treatment of renal disease. In addition, SRP has agreed to be the manufacturer of record for licensors of the technology outside of the field of the treatment of renal disease. Additional terms were not disclosed.

SRP intends to develop and market a filtration system for use in conjunction with the disposable tubing circuit sets used in treatments that provide continuous renal replacement therapy (CRRT). The system will apply to patients who present in the intensive care unit with acute kidney injury (AKI). CRRT allows the clinician the ability to manage unstable AKI patients by offering slower ultrafiltration and solute removal. Some advantages with performing CRRT continuously (24 hours per day) include improved hemodynamic tolerance and more control over the total volumes given and removed from unstable AKI patients.

Additionally, Dr. Stephen Ash, CEO and Medical Director of HCT, has agreed to join the board of directors of SRP. Dr. Ash has been a pioneer and innovation leader in the nephrology field for over 30 years. Dr. Ash is a practicing Nephrologist at Indiana University Health Arnett in Lafayette, Indiana. In addition to his role at HCT, Dr. Ash is Chairman of the Board of Ash Access Technology and co-founder of several spin-off biotechnology firms.  He has a long history of research and product development in the field of sorbents, resulting in devices for the treatment of kidney failure (Allient™ by Renal Solutions) and liver failure (Liver Dialysis by HemoTherapies). For hyperkalemia, he was instrumental in development of an orally ingested sorbent (ZS-9 by ZS Pharma, now part of Astra Zeneca). Dr. Ash has also invented many new catheters for dialysis access, including the Ash Split Cath®, CentrosFLO® and Advantage™ PD Catheter.

“This is an exciting opportunity for SRP and we look forward to working with Dr. Ash to bring this promising therapy to market,” said Monet Carnahan, R.N., Director of Dialysis Products at Nephros. “SRP is focused on improving the lives of patients with renal disease, and this technology provides an innovative solution that may improve continuous veno-venous hemodialysis therapy, both in terms of ease-of-use for nurses and improved patient outcomes.”

“I have been impressed with the Nephros team and believe they are the right partners to develop and commercialize the dialysate regeneration and filtration system,” said Dr. Stephen Ash, co-founder of HemoCleanse Technologies. “In addition, I am excited to join the SRP board, and help bring additional therapies to patients with renal disease. SRP’s hemodiafiltration system has a unique opportunity to potentially change the quality of life and outcomes for some ESRD patients.”

CRRT Background
Technologically, CRRT is different from standard HD in that CRRT devices rely on bags of dialysate to provide the treatment, while HD devices generate dialysate in real-time from ultrapure water and dialysate concentrate.

Achieving the treatment goal for AKI without causing the patient to become hemodynamically unstable requires the removal of the water and toxins to be much slower, and to take place over an extended period of time. One treatment modality of CRRT is continuous veno-venous hemodialysis (CVVHD), which provides continuous therapy, maximizes the amount of ultrafiltration possible per day, and removes middle molecules (similar to hemodiafiltration). The disadvantages of CVVHD include the labor and cost associated with replacing the dialysate bag up to 8 times per day to provide up to 40 liters of fresh fluid, the low dialysate flow rate, and the excessive removal of small molecules, which can require hospital pharmacies to add supplements to the dialysate bags prior to use, further increasing the cost of treatment. SRP and HCT believe that a carbon-based filtration system inserted into the disposable CVVHD circuit may enable the regeneration of patient’s sterile dialysate, reducing the overall total sterile fluid usage. In addition, by removing more uremic toxins and middle molecules, the system may improve the clinical response seen with patients and allow for higher dialysate flow rates.

About Specialty Renal Products, Inc. and Nephros, Inc.
Specialty Renal Products, a subsidiary of Nephros, is focused on the development of medical device products for patients with renal disease, including a hemodiafiltration system for the treatment of patients with ESRD.

Nephros is a commercial stage medical device company that develops and sells high performance liquid purification filters. Nephros filters – known as ultrafilters – are used primarily in medical applications in various settings. These ultrafilters are used by dialysis centers for assisting in the added removal of biological contaminants from the water and bicarbonate concentrate supplied to hemodialysis machines and the patients. Additionally, Nephros ultrafilters are used in hospitals and medical clinics for added protection in retaining bacteria (i.e. Legionella, Pseudomonas), virus and endotoxin from water. These ultrafilters provide barriers that assist in improving infection control with showers, sinks, and ice machines.

For more information about Nephros, please visit its website at www.nephros.com.

Nephros Appoints Oliver Spandow to its Board of Directors

Source:  Nephros, Inc.-August 13, 2018

Seasoned Executive Adds Significant Operational and M&A Expertise

Nephros, Inc. (OTCQB: NEPH), a commercial stage medical device company that develops and sells high performance liquid purification ultrafilters announced today the appointment of Oliver Spandow to its Board of Directors.

Mr. Spandow is currently the CFO, Executive Vice President and a member of the board of directors of IDOC, LLC, an optometry-based consulting and member service organization. Prior to IDOC, Mr. Spandow spent 15 years with Johnson and Johnson (J&J), including roles as the General Manager of the JNJ Vision Care business in the United Kingdom and Ireland, Vice President of Strategic Accounts and Business Insights at Vistakon (J&J) USA, and Vice President, Finance and CFO of Vistakon (J&J) USA. While at JNJ, in addition to general finance, sales and marketing roles, he was involved with multiple acquisitions, divestment, and licensing deals. Prior to J&J, Mr. Spandow was a Management Consultant with Price Waterhouse. Mr. Spandow holds a B.S. in Finance from the University of Connecticut and an MBA from the Fuqua School of Business, Duke University.

 “We are very excited to have Oliver join our Board,” said Daron Evans, CEO of Nephros. “Oliver’s experience with transactions and organization scale-up in the medical device space provides Nephros with a valuable resource as we continue to focus on expansion.”

“The Nephros team has done a great job over the last few years building a self-sustaining, growing business,” said Mr. Spandow. “I am excited to join the company’s board at this time of rapid growth.  I look forward to working closely with the management team to help Nephros achieve its full growth potential in its core infection control and dialysis water businesses, as well as participating in the evaluation of potential strategic steps to broaden its market segments and product portfolio.”

About Nephros, Inc.
Nephros is a commercial stage medical device company that develops and sells high performance liquid purification filters, as well as a hemodiafiltration system for the treatment of patients with End Stage Renal Disease through its Specialty Renal Products, Inc. subsidiary. Nephros filters or ultrafilters are used primarily in medical applications in various settings. These ultrafilters are used by dialysis centers for assisting in the added removal of biological contaminants from the water and bicarbonate concentrate supplied to hemodialysis machines and the patients. Additionally, Nephros ultrafilters are used in hospitals and medical clinics for added protection in retaining bacteria (i.e. Legionella, Pseudomonas), virus and endotoxin from water. These ultrafilters provide barriers that assist in improving infection control with showers, sinks, and ice machines.

For more information about Nephros, please visit its website at www.nephros.com.


Nephros Reports Second Quarter 2018 Financial Results


Source:  Nephros, Inc.-August 8, 2018

Nephros, Inc. (OTCQB: NEPH) (“Nephros”), a commercial stage medical device company that develops and sells high performance liquid purification ultrafilters and an on-line mid-dilution hemodiafiltration system for use with a hemodialysis (HD) machine for the treatment of patients with End Stage Renal Disease (ESRD), today announced financial results for the three months ended June 30, 2018.

“Today’s results represent our eighth consecutive quarter of year-over-year revenue growth averaging 59%,” said Daron Evans, President and CEO. “We believe this consistent growth in our ultrafilter solutions reflects increasing confidence from both our customers and our valued distribution partners, and we are confident that we are strongly positioned for the future.”

Nephros also announced plans today to pursue listing on a national stock exchange. As part of this effort and in order to satisfy stock price listing criteria, Nephros intends to initiate a reverse split of its common stock in approximately thirty days.

“Given our growth and strong balance sheet, we have begun the process of uplisting to a national stock exchange,” said Andy Astor, CFO. “An uplist is likely to increase the visibility and liquidity of Nephros’s stock, with a broader audience of additional investors who will be able to consider investing in Nephros.”

Financial Performance for the Quarter Ended June 30, 2018
Product revenues for the three months ended June 30, 2018 were approximately $1,216,000, compared to approximately $785,000 for the three months ended June 30, 2017, an increase of approximately $431,000, or 55%. Total revenues for the three months ended June 30, 2018 were approximately $1,366,000, compared to approximately $858,000 for the three months ended June 30, 2017, an increase of approximately $508,000, or 59%.

Cost of goods sold was approximately $536,000 for the three months ended June 30, 2018, compared to approximately $341,000 for the three months ended June 30, 2017. Research and development expenses were approximately $352,000 and $277,000 for the three months ended June 30, 2018 and 2017, respectively. Selling, general and administrative expenses were approximately $1,091,000 for the three months ended June 30, 2018, compared to approximately $881,000 for the three months ended June 30, 2017, representing an increase of $210,000, or 24%.

As of June 30, 2018, Nephros had cash and cash equivalents of approximately $3,484,000.