Delaware
|
| |
3845
|
| |
68-0533453
|
(State or Other Jurisdiction of
Incorporation or Organization)
|
| |
(Primary Standard Industrial
Classification Code Number)
|
| |
(I.R.S. Employer
Identification Number)
|
Phillip D. Torrence
Honigman LLP
650 Trade Centre Way, Suite 200
Kalamazoo, MI 49002
Tel: (269) 337-7700
Fax: (269) 337-7703
|
| |
Neil P. Ayotte
Senior Vice President, General
Counsel,
Secretary and Chief Compliance
Officer
Nuwellis, Inc.
12988 Valley View Road
Eden Prairie, Minnesota 55344
Tel: (952) 345-4200
|
| |
David E. Danovitch
Aaron M. Schleicher
Sullivan & Worcester LLP
1633 Broadway
New York, New York 10019
(212) 660-3060
|
Large accelerated filer
|
| |
☐
|
| |
Accelerated filer
|
| |
☐
|
Non-accelerated filer
|
| |
☒
|
| |
Smaller reporting company
|
| |
☒
|
|
| |
|
| |
Emerging growth company
|
| |
☐
|
|
| |
Per Unit
|
| |
Per Pre-Funded Unit
|
| |
Total
|
Public offering price
|
| |
$
|
| |
$
|
| |
$
|
Placement agent fees(1)
|
| |
$
|
| |
$
|
| |
$
|
Proceeds to us (before expenses)
|
| |
$
|
| |
$
|
| |
$
|
(1)
|
We have agreed to pay the placement agents a cash fee equal to 8.0% of the aggregate gross proceeds raised in this offering, and to
reimburse the placement agents for certain of their offering-related expenses. See “Plan of Distribution (Conflicts of Interest)” for a description of the compensation to be received by the placement agents.
|
LAKE STREET
|
| |
|
| |
MAXIM GROUP LLC
|
1
|
Murugan R et al. Nature Rev Nephrol. 2020; 1-14.
|
2
|
Koratala A et al. Cardiorenal Med. 2022;12(4):141-154.
|
3
|
Vaara ST et al. Crit Care.2012; 16: 1-11.
|
4
|
Koratala A et al Cardiorenal Med. 2022;12(4):141-154
|
5
|
Stein, A, et. al. Critical Care, 2012:16:R99.
|
6
|
Iribarne A, et al. Ann Thorac Surg. 2014; 98(4): 1274-80.
|
7
|
Ronco C, Costanzo MR, Bellomo R, et al. (2010) Fluid Overload Diagnosis and Management. Basel,
Switzerland: Karger.
|
8
|
Sutherland SM, et al. Am J Kidney Disease. 2010; 5(2): 316-25.
|
9
|
Gillespie RS, et al. Ped Nephro. 2004; 19(12): 1394-99.
|
10
|
Kazory A & Costanzo MR. Adv Chronic
Kidney Dis. 2018; 25(5): 434-442.
|
11
|
Fonarow GC. Rev Cardiovasc Med. 2003; 4: s21-30.
|
12
|
Kamath SA. Int J of Nephrol. 2011; 1-6.
|
13
|
Ellison DH. Cardio.2001;96:132-143
|
14
|
Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445.
|
15
|
From Premier Applied Sciences database.
|
16
|
Reimbursement estimates from MCRA.
|
17
|
Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445.
|
18
|
McIlvennan CK, Eapen ZJ, Allen LA. Circulation. 2015 May 19;131(20):1796-803.
|
20
|
Ahmed A, et al. Eur Heart J. 2006 Jun;27(12):1431-9.
|
21
|
Kazory A & Costanzo MR. Adv Chronic
Kidney Dis. 2018; 25(5): 434-442; 30.
|
22
|
Testani JM, Hanberg JS, Cheng S et al. Circ
Heart Fail. 2016; 9(1): e002370.
|
24
|
Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445.
|
25
|
Kamath SA. Int J of Nephrol. 2011: 1-6.
|
26
|
Felker MG & Mentz RJ. J Am Coll
Cardiol. 2012;59(24):2145-53.
|
27
|
Testani JM. Circ Heart Fail. 2016 Jan;9(1):e002370.
|
28
|
Hoorn EJ & Ellison DH. Am J Kidney
Dis. 2017;69(1):136-142.
|
29
|
Gheorghiade M, et al. Eur Heart J Suppl. 2005; 7:B13– 19.
|
30
|
Orso D, et al. Eur Rev Med Pharmacol Sci. 2021 Apr;25(7):2971-2980.
|
31
|
Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428- 2445.
|
32
|
Thandra A, et al. Clin Invest. 2023; 365(2): 145-51.
|
33
|
Felker GM, et al. N Engl J Med. 2011; 364:797–805.
|
34
|
Costanzo MR, et al. J Am Coll Cardiol. 2007; 49(6):675-683.
|
•
|
Reduces hospitalization by 81%40 compared to diuretics;
|
•
|
Rehospitalizations with Aquadex were 48% lower than the national average at 30 days;41
|
•
|
Reduces length of hospital stay when initiated early, resulting in average savings of $3,975 (14%);42
|
•
|
Stabilizes or improves cardiac hemodynamics;43, 44
|
•
|
Safe, easy-to-use, and flexible in application;
|
•
|
Provides complete control over rate and total volume of fluid removed by allowing a medical practitioner to specify the amount
of fluid to be removed from each individual patient;
|
•
|
Can be performed via peripheral or central venous access;
|
•
|
Predictably removes excess isotonic fluid (extracts water and sodium while sparing potassium and magnesium; decrease risk of
electrolyte abnormalities);45, 46
|
35
|
Agostoni PG, et al. J Am Coll Cardiol. 1993; 21(2):424-431.
|
36
|
Kazory A, et al. Cardiorenal Med. 2023;13(1)1-8.
|
37
|
Costanza MR, et. al. Value Health. 2018; 21 (Suppl 1):S167.
|
38
|
SAFE Trial: Jaski BE, et al. J Card Fail. 2003; 9(3): 227-231.
|
39
|
RAPID Trial: Bart BA, et al. J Am Coll
Cardiol. 2005; 46(11): 2043-2046.
|
40
|
Watson R et al. Am Heart J Plus: Cardiol:
Res & Pract. 2022; 242:1-6.
|
41
|
Watson R et al. Am Heart J Plus: Cardiol:
Res & Pract. 2022; 242:1-6.
|
42
|
Costanza MR, et. al. Value Health. 2018; 21 (Suppl 1):S167.
|
43
|
Boga M, et al. Perf. 2000; 15:143-150.
|
44
|
Kiziltepe U, et al. Ann Thorac Surg 2001;71:684–93.
|
45
|
Kazory A, et al. Cardiorenal Med. 2023;13(1)1-8.
|
46
|
Agostoni PG et al. J Am Coll Cardiol. 1993;21(2):424-31.
|
•
|
No significant changes to kidney function;47
|
•
|
The use of continuous hematocrit monitoring and SvO2 sensor provides guided-therapy ultrafiltration.48
|
•
|
Following ultrafiltration, neurohormonal activation is reset toward a more physiological condition and diuretic efficacy is
restored;49
|
•
|
Provides highly automated operation with only one setting required to begin therapy;
|
•
|
Utilizes a single-use, disposable auto-loading blood filter circuit that facilitates easy set-up; and
|
•
|
Has a built-in console that guides the medical practitioner through the setup and operational process.
|
•
|
A console, a piece of capital equipment containing electromechanical pumps, an LCD screen and stand;
|
•
|
A one-time disposable blood circuit set, an integrated collection of tubing, filter, sensors, and connectors that contain and
deliver the blood from and back to the patient; and
|
•
|
A disposable catheter, a small, dual-lumen, extended length catheter designed to access the peripheral venous system of the
patient and to simultaneously withdraw blood and return filtered blood to the patient.
|
47
|
Kazory A, et al. Cardiorenal Med. 2023;13(1)1-8.
|
48
|
Starr MC, et al. Pediatric Nephrology. 2024; 39(2):597-601.
|
49
|
Costanzo MR, et al. J Am Coll Cardiol. 2005; 46(11): 2047-51.
|
50
|
Shah, K, et al. J Am Coll Cardiol. 2017 Nov, 70 (20) 2476–2486.
|
51
|
Bozhurt B, et al. J Card Fail. J Card Fail. 2023; 29(10): 1412-42.
|
52
|
Benjamin EJ, et al. Circ. 2017;135:00-00. (e378).
|
53
|
Fonarow GC, et al. Rev Cardiovasc Med. 2003; 4: s21-30.
|
54
|
Testani JM, et al. Circ Heart Fail. 2016; 9(1): e002370.
|
55
|
Arrigo M et al. Nat Rev Dis Primers. 2020; 6(16):1-15.
|
56
|
Fonarow et al. Rev Cardiovasc Med. 2003;4: Suppl 7:S21-30.
|
57
|
Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445.
|
58
|
Sax D, et al. J Card Fail. 2022: 28(10): 1545-59.
|
59
|
Voigt J, et al. Clin Cardiol. 2014;37(5): 312–321.
|
60
|
Heidenreich PA, et al. Circ Heart Fail. 2013;6(3):606-619.
|
61
|
McIlvennan C et al. Circ. 2015; 131(20): 1796-1803.
|
62
|
See Appendix to Company Investor Presentation filed with the SEC on Form 8-K/A, dated January 9,
2024.
|
63
|
https://idataresearch.com/new-study-shows-approximately-340000-cabg-procedures-per-year-in-the-united-states/.
|
64
|
https://idataresearch.com/over-182000-heart-valve-replacements-per-year-in-the-united-states/.
|
65
|
Grand View Research. Market Research Report. 2015; 978-1-68038-603-5.
|
66
|
Kruger A et al. J Cardiovasc Dev Dis. 2023;10(6);263-78.
|
67
|
Bowdish ME, et al. Ann Thorac Surg. 2021;111(6):1770-1780.
|
68
|
Xu J, et al. Medicine. 2015.94(33):e1360.
|
69
|
Xu J, et al. Medicine. 2015;94(33):e1360.
|
70
|
Granado RC et al. BMC Nephro. 2016;17:109-18.
|
71
|
Crawford TC, et al. Ann Thorac Surg. 2017;103:32-40.
|
72
|
Iribane A, et al. Ann Thorac Surg. 2014;98:1274-80.
|
73
|
Iribarne A, et al. Ann Thorac Surg. 2014 Oct; 98(4): 1274-80.
|
74
|
Beckles DL et al. J Card Surg.2022; 37: 2951-57.
|
75
|
Engelman D, et al. Ann Thorac Surg. 2023;115:11-5A
|
76
|
See Appendix to Company Investor Presentation filed with the SEC on Form 8-K/A, dated January 9,
2024.
|
77
|
Jayaprasad, N. Heart Views. 2016; 17(3): 92–99.
|
78
|
https://www.cdc.gov/ncbddd/heartdefects/data.html.
|
79
|
Karamlou T, et al. J Thorac Cardiovasc
Surg. 2013 Feb; 145(2):470-5.
|
80
|
https://www.organdonor.gov/about/donors/child-infant.html.
|
81
|
Sutherland SM, et al. Am J Kidney Dis. 2010; 55(2):315-25.
|
82
|
Gillespie RS, et al. Ped Nephro. 2004; 19(12):1394-99.
|
83
|
See Appendix to Company Investor Presentation filed with the SEC on Form 8-K/A, dated January 9,
2024.
|
•
|
Composite win ratio analysis of Cardiovascular (CV) mortality, HF events, and quality of life within 30 days:
|
○
|
CV mortality
|
○
|
HF event
|
○
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
|
•
|
Time to first HF event within 90 days
|
•
|
Time to first HF event or all-cause death within 90 days
|
•
|
HF events within 30 and 90 days
|
•
|
Treatment crossovers
|
84
|
Watson R, et al. Am Heart J Plus: Cardiol
Res & Pract 24. 2022; 1-6.
|
85
|
Watson R, et al. Am Heart J Plus: Cardiol
Res & Pract 24. 2022; 1-6.
|
86
|
Kazory et al. Cardiorenal Med. 2023;13:1-8.
|
87
|
Kazory A, et al. Cardio Renal Med. 2023.12(1):1-8.
|
88
|
Costanzo MR, et al. Val in Health. 2018: 21(1): s167.
|
89
|
Costanzo MR, et al. JACC: Heart Failure. 2016;4(2):95-105.
|
90
|
Menon S, et al. Clin J Am Soc Nephrol. 2019;14(10):1432-1440.
|
91
|
Menon S, et al. Clin J Am Soc Nephrol. 2019;14(10):1432-1440.
|
•
|
110,916 shares of our common stock issuable upon the exercise of outstanding stock options, having a weighted average exercise
price of $35.90 per share;
|
•
|
2,963,192 shares of our common stock issuable upon the exercise of outstanding warrants (other than the warrants offered hereby)
with a weighted-average exercise price of $30.86 per share;
|
•
|
125,857 shares of our common stock issuable upon the conversion of the 127 outstanding shares of our Series F Preferred Stock;
|
•
|
295,792 shares of our common stock issuable upon the conversion of the 11,950 outstanding shares of our Series J Convertible
Preferred Stock;
|
•
|
1,656,361 shares of our common stock issuable upon conversion of 66,917 Series J Convertible Preferred Stock issuable upon the
exercise of 133,834 warrants issued in the October 2023 Offering; and
|
•
|
41,871 shares of our common stock reserved for future issuance under our equity incentive plans.
|
•
|
We have limited history of operations and limited experience in sales and marketing, and we might be unsuccessful in increasing
our sales and cannot assure you that we will ever generate substantial revenue or be profitable.
|
•
|
We have incurred operating losses since our inception and anticipate that we will continue to incur operating losses in the
near-term. To date, we have been funded by equity financings, and although we believe that we will be able to successfully fund our operations, there can be no assurance that we will be able to do so or that we will ever operate
profitably. If this financing is not successful or if we raise less than we intend, we will need to raise additional capital to fund our operations through the end of fiscal year 2024. If additional capital is not available, we will
have to delay, reduce or cease operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern through the next twelve months.
|
•
|
Our near-term prospects are highly dependent on revenues from a single product, the Aquadex System. We face significant
challenges in expanding market acceptance of the Aquadex System, which could adversely affect our potential sales.
|
•
|
Nasdaq may delist our common stock from its exchange which could limit your ability to make transactions in our securities and
subject us to additional trading restrictions.
|
•
|
We depend on a limited number of customers, the loss of which, or failure of which to order our products in a particular period,
could cause our revenues to decline.
|
•
|
We have limited commercial manufacturing experience and could experience difficulty in producing commercial volumes of the
Aquadex System and related components or may need to depend on third parties for manufacturing.
|
•
|
We depend upon third-party suppliers, including single source suppliers, making us vulnerable to supply problems and price
fluctuations.
|
•
|
The COVID-19 outbreak and other public health threats or outbreaks of communicable diseases could have a material adverse effect
on our operations and overall financial performance.
|
•
|
We have been negatively impacted by the prioritization of COVID-19 patients in hospitals.
|
•
|
If we cannot develop adequate distribution, customer service and technical support networks, then we may not be able to market
and distribute the Aquadex System effectively and our sales will suffer.
|
•
|
We compete against many companies, some of which have longer operating histories, more established products and greater
resources than we do, which may prevent us from achieving further market penetration or improving operating results.
|
•
|
The competition for qualified personnel is particularly intense in our industry. If we are unable to retain or hire key
personnel, we may not be able to sustain or grow our business.
|
•
|
Significant additional governmental regulation could subject us to unanticipated delays which would adversely affect our sales.
|
•
|
Product defects, resulting in lawsuits for product liability, could harm our business, results of operations and financial
condition.
|
•
|
We may face significant risks associated with international operations, which could have a material adverse effect on our
business, financial condition and results of operations.
|
•
|
If we are not able to maintain sufficient quality controls, then the approval or clearance of our products by the European
Union, the FDA or other relevant authorities could be withdrawn, delayed or denied and our sales will suffer.
|
•
|
If we violate any provisions of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) or any other statutes or regulations, then
we could be subject to enforcement actions by the FDA or other governmental agencies.
|
•
|
We cannot assure you that our products will be safe or that there will not be serious injuries or product malfunctions. Further,
we are required under applicable law to report any circumstances relating to our medically approved products that could result in deaths or serious injuries. These circumstances could trigger recalls, class action lawsuits and other
events that could cause us to incur expenses and may also limit our ability to generate revenues from such products.
|
•
|
We face significant uncertainty in the industry due to government healthcare reform.
|
•
|
We are subject, directly or indirectly, to United States federal and state healthcare fraud and abuse and false claims laws and
regulations. Prosecutions under such laws have increased in recent years and we may become subject to such litigation. If we are unable to, or have not fully complied with such laws, we could face substantial penalties.
|
•
|
Failure to comply with anti-bribery, anti-corruption, and anti-money laundering laws could subject us to penalties and other
adverse consequences.
|
•
|
If we acquire other businesses, products or technologies, we could incur additional impairment charges and will be subject to
risks that could hurt our business.
|
•
|
We may not be able to protect our intellectual property rights effectively, which could have an adverse effect on our business,
financial condition or results of operations.
|
•
|
Intellectual property litigation could be costly and disruptive to us.
|
•
|
If we were unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and
system could be adversely affected.
|
•
|
Our products could infringe patent rights of others, which may require costly litigation and, if we are not successful, could
cause us to pay substantial damages or limit our ability to commercialize our products.
|
•
|
We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former
employers.
|
•
|
Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent
us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
|
•
|
The trading price of our common stock price has been, and could continue to be, volatile.
|
•
|
The rights of holders of our capital stock will be subject to, and could be adversely affected by, the rights of holders of our
outstanding preferred stock and stock that may be issued in the future.
|
•
|
A more active, liquid trading market for our common stock may not develop, and the price of our common stock may fluctuate
significantly.
|
•
|
If we do not comply with certain tax regulations, including VAT, and similar regulations, we may be subject to additional taxes,
customs duties, interest, and penalties in material amounts, which could materially harm our financial condition and operating results.
|
•
|
Our ability to use U.S. net operating loss carryforwards and other tax attributes might be limited.
|
•
|
We do not intend to pay cash dividends on our common stock in the foreseeable future.
|
•
|
There may be future sales of our securities or other dilution of our equity, which may adversely affect the market price of our
common stock.
|
•
|
This is a best-efforts offering, no minimum amount of securities is required to be sold, and we may not raise the amount of
capital we believe is required for our business plans.
|
•
|
our quarterly or annual operating results;
|
•
|
changes in our earnings estimates;
|
•
|
investment recommendations by securities analysts following our business or our industry;
|
•
|
additions or departures of key personnel;
|
•
|
changes in the business, earnings estimates or market perceptions of our competitors;
|
•
|
our failure to achieve operating results consistent with securities analysts’ projections;
|
•
|
future announcements concerning us, including our clinical and product development strategy,
|
•
|
or our competitors;
|
•
|
regulatory developments, disclosure regarding completed, ongoing or future clinical studies and
|
•
|
enforcement actions bearing on advertising, marketing or sales;
|
•
|
acquisition or loss of significant manufacturers, distributors or suppliers or an inability
|
•
|
to obtain sufficient quantities of materials needed to manufacture our system;
|
•
|
fluctuations of investor interest in the medical device sector;
|
•
|
changes in industry, general market or economic conditions; and
|
•
|
announcements of legislative or regulatory changes.
|
•
|
apply for MDR certification with an MDR notified body by 26 May 2024 and before their MDD certificate expires, and
|
•
|
have a contract in place with an MDR notified body before 26 September 2024.
|
•
|
The existence of other opportunities or the need to take advantage of changes in timing of our existing activities;
|
•
|
The need or desire on our part to accelerate, increase or eliminate existing initiatives due to, among other things, changing
market conditions and competitive developments; and/or
|
•
|
If strategic opportunities present themselves (including acquisitions, joint ventures, licensing and other similar transactions).
|
|
| |
As of September 30, 2023
(in thousands, except
share and per share data)
|
||||||
|
| |
Actual
|
| |
Pro Forma
|
| |
Pro Forma As
Adjusted
|
Cash and cash equivalents
|
| |
$4,930
|
| |
$6,412
|
| |
$13,399
|
Stockholders’ equity:
|
| |
|
| |
|
| |
|
Series A junior participating preferred stock, par value
$0.0001 per share; authorized 30,000 shares, none outstanding actual, pro forma and pro forma as adjusted
|
| |
—
|
| |
—
|
| |
—
|
Series F convertible preferred stock, par value $0.0001
per share; authorized 18,000 shares, issued and outstanding 127 shares actual, pro forma and pro forma as adjusted
|
| |
—
|
| |
—
|
| |
—
|
Series J convertible preferred stock, par value $0.0001
per share; authorized 600,000 shares, issued and outstanding 0, 150,000 and 150,000 shares, actual, pro forma and pro forma as adjusted, respectively
|
| |
—
|
| |
—
|
| |
—
|
Common stock, par value $0.0001 per share; authorized
100,000,000 shares, issued and outstanding 1,864,265, 1,864,265 and 18,530,931 shares actual, pro forma and pro forma as adjusted, respectively
|
| |
—
|
| |
—
|
| |
2
|
Additional paid-in capital
|
| |
289,980
|
| |
291,462
|
| |
298,447
|
Accumulated other comprehensive income:
|
| |
|
| |
|
| |
|
Foreign currency translation adjustment
|
| |
(24)
|
| |
(24)
|
| |
(24)
|
Unrealized gain on marketable securities
|
| |
—
|
| |
—
|
| |
|
Accumulated deficit
|
| |
(282,117)
|
| |
(282,117)
|
| |
(282,117)
|
Total stockholders’ equity
|
| |
$7,839
|
| |
$9,321
|
| |
$16,308
|
•
|
111,275 shares of our common stock issuable upon the exercise of outstanding stock options, having a weighted average exercise
price of $36.78 per share;
|
•
|
1,308,271 shares of our common stock issuable upon the exercise of outstanding warrants (other than the warrants offered hereby)
with a weighted-average exercise price of $35.51 per share;
|
•
|
5,080 shares of our common stock issuable upon the conversion of the 127 outstanding shares of our Series F Preferred Stock;
|
•
|
3,712,871 shares of our common stock issuable upon the conversion of the 150,000 outstanding shares of our Series J Convertible
Preferred Stock;
|
•
|
1,856,435 shares of common stock issuable upon the conversion of 75,000 Series J Convertible Preferred Stock issuable upon the
exercise of the 150,000 warrants issued in the October 2023 Offering; and
|
•
|
49,456 shares of our common stock reserved for future issuance under our equity incentive plans.
|
(in thousands)
|
| |
|
| |
|
| |
|
Three months ended
September 30, 2023
|
| |
Three months ended
September 30, 2022
|
| |
Increase
(Decrease)
|
| |
%
Change
|
$2,412
|
| |
$2,065
|
| |
$347
|
| |
16.8%
|
(in thousands)
|
| |
Three months ended
September 30, 2023
|
| |
Three months ended
September 30, 2022
|
| |
Increase
(Decrease)
|
| |
%
Change
|
Cost of goods sold
|
| |
$1,031
|
| |
$806
|
| |
$225
|
| |
27.9%
|
Selling, general and administrative
|
| |
$3,428
|
| |
$4,251
|
| |
$(823)
|
| |
(19.4)%
|
Research and development
|
| |
$1,117
|
| |
$928
|
| |
$189
|
| |
20.4%
|
(in thousands)
|
| |
|
| |
|
| |
|
Nine months ended
September 30, 2023
|
| |
Nine months ended
September 30, 2022
|
| |
Increase
(Decrease)
|
| |
%
Change
|
$6,313
|
| |
$6,204
|
| |
$109
|
| |
1.8%
|
(in thousands)
|
| |
Nine months ended
September 30, 2023
|
| |
Nine months ended
September 30, 2022
|
| |
Increase
(Decrease)
|
| |
%
Change
|
Cost of goods sold
|
| |
$2,718
|
| |
$2,780
|
| |
$(62)
|
| |
(2.2)%
|
Selling, general and administrative
|
| |
$13,582
|
| |
$12,920
|
| |
$662
|
| |
5.1%
|
Research and development
|
| |
$4,050
|
| |
$3,141
|
| |
$909
|
| |
28.9%
|
92
|
Murugan R et al. Nature Rev Nephrol. 2020; 1-14.
|
93
|
Vaara ST et al. Crit Care. 2012; 16: 1-11.
|
94
|
Koratala A et al. Cardiorenal Med. 2022;12(4):141-154.
|
95
|
Stein, A, et. al. Critical Care; 2012:16:R99.
|
96
|
Iribarne A, et al. Ann Thorac Surg. 2014; 98(4): 1274-80.
|
97
|
Salahuddin N et al. BMC Nephro. 222017;18(1):1-8.
|
98
|
Ronco C, et al. (2010) Fluid Overload Diagnosis and Management. Basel, Switzerland: Karger.
|
99
|
Sutherland SM, et al. Am J Kidney Disease. 2010; 5(2): 316-25.
|
100
|
Gillespie RS, et al. Ped Nephro. 2004; 19(12): 1394-99.
|
101
|
Kazory A & Costanzo MR. Adv Chronic
Kidney Dis. 2018; 25(5): 434-442.
|
102
|
Fonarow GC. Rev Cardiovasc Med. 2003; 4: s21-30.
|
103
|
Kamath, SA. Int J of Nephrol. 2011; 1-6.
|
104
|
Ellison DH. Cardiol. 2001;96:132-143
|
105
|
Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445.
|
106
|
From Premier Applied Sciences database.
|
107
|
Reimbursement estimates from MCRA.
|
108
|
Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445.
|
109
|
McIlvennan CK, et al. Circ. 2015;131(20):1796-803.
|
110
|
From Premier Applied Sciences database.
|
111
|
Ahmed A, et al. Eur Heart J. 2006;27(12):1431-9.
|
112
|
Kazory A & Costanzo MR. Adv Chronic
Kidney Dis. 2018; 25(5): 434-442; 30.
|
113
|
Testani JM, et al. Circ Heart Fail. 2016; 9(1): e002370.
|
114
|
Testani JM, et al. Circ Heart Fail. 2016; 9(1): e002370.
|
115
|
Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445.
|
116
|
Kamath SA. Int J of Nephrol. 2011:1-6.
|
117
|
Felker MG & Mentz RJ. J Am Coll Cardiol. 2012;59(24):2145-53.
|
118
|
Testani JM, et al. Circ Heart Fail. 2016;9(1):e002370.
|
119
|
Hoorn EJ & Ellison DH. Am J Kidney Dis. 2017;69(1):136-142.
|
120
|
Gheorghiade M, et al. Eur Heart J Suppl. 2005; 7:B13–19.
|
121
|
Orso D, et al. Eur Rev Med Pharmacol Sci. 2021;25(7):2971-2980.
|
122
|
Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445.
|
123
|
Thandra A, et al. Clin Invest. 2023; 356(2): 145-51.
|
124
|
Felker GM, et al. N Engl J Med. 2011; 364:797–805.
|
125
|
Costanzo MR, et al. J Am Coll Cardiol. 2007; 49(6):675-683.
|
•
|
Reduces hospitalization by 81%131 compared to diuretics;
|
•
|
Rehospitalizations with Aquadex were 48% lower than the national average at 30 days;132
|
•
|
Reduces length of hospital stay when initiated early, resulting in average savings of $3,975 (14%);133
|
•
|
Stabilizes or improves cardiac hemodynamics;134, 135
|
•
|
Safe, easy-to-use, and flexible in application;
|
•
|
Provides complete control over rate and total volume of fluid removed by allowing a medical practitioner to specify the amount of
fluid to be removed from each individual patient;
|
•
|
Can be performed via peripheral or central venous access;
|
•
|
Predictably removes excess isotonic fluid (extracts water and sodium while sparing potassium and magnesium; decrease risk of
electrolyte abnormalities);136, 137
|
•
|
No significant changes to kidney function;138
|
126
|
Agostoni PG, et al. J Am Coll Cardiol. 1993; 21(2):424-431.
|
127
|
Kazory A,et al. Cardiorenal Med. 2023;13(1)1-8.
|
128
|
Costanza MR, et. al. Value Health. 2018; 21 (Suppl 1):S167.
|
129
|
SAFE Trial: Jaski BE, et al. J Card Fail. 2003; 9(3): 227-231; RAPID Trial.
|
130
|
Bart BA, et al. J Am Coll Cardiol. 2005; 46(11): 2043-2046.
|
131
|
Watson R et al. J Cardiac Fail. 2020; 26(10): s56.
|
132
|
Watson R et al. J Cardiac Fail. 2020; 26(10): s56.
|
133
|
Costanza MR, et. al. Value Health. 2018; 21 (Suppl 1):S167.
|
134
|
Boga M, et al. Perf. 2000; ;15:143-150.
|
135
|
Kiziltepe U, et al. Ann Thorac Surg 2001;71:684–93.
|
136
|
Kazory A, et al. Cardiorenal Med. 2023;13(1)1-8.
|
137
|
Agostoni PG et al. J Am Coll Cardiol. 1993;21(2):424-31.
|
138
|
Kazory A, et al. Cardiorenal Med. 2023;13(1)1-8.
|
•
|
The use of continuous hematocrit monitoring and SvO2 sensor provides guided-therapy ultrafiltration.139
|
•
|
Following ultrafiltration, neurohormonal activation is reset toward a more physiological condition and diuretic efficacy is
restored;140
|
•
|
Provides highly automated operation with only one setting required to begin therapy;
|
•
|
Utilizes a single-use, disposable auto-loading blood filter circuit that facilitates easy set-up; and
|
•
|
Has a built-in console that guides the medical practitioner through the setup and operational process.
|
•
|
A console, a piece of capital equipment containing electromechanical pumps, an LCD screen and stand;
|
•
|
A one-time disposable blood circuit set, an integrated collection of tubing, filter, sensors, and connectors that contain and
deliver the blood from and back to the patient; and
|
•
|
A disposable catheter, a small, dual-lumen, extended length catheter designed to access the peripheral venous system of the
patient and to simultaneously withdraw blood and return filtered blood to the patient.
|
139
|
Starr MC, et al. Ped Nephro. 2024;39(2):597-601.
|
140
|
Costanzo MR, et al. J Am Coll Cardiol. 2005; 46(11): 2047-51.
|
141
|
Shah, K, et al. J Am Coll Cardiol. 2017 Nov, 70 (20) 2476–2486.
|
142
|
Bozhurt B, et al. J Card Fail. 2023; 29(10): 1412-42.
|
143
|
Benjamin EJ, et al. Circ. 2017;135:00-00. (e378).
|
144
|
Fonarow GC. Rev Cardiovasc Med. 2003; 4: s21-30.
|
145
|
Testani JM, et al. Circ Heart Fail. 2016; 9(1): e002370.
|
146
|
Arrigo M et al. Nat Rev Dis Primers.2020;6(16):1-15.
|
147
|
Fonarow et al. Rev Cardiovasc Med. 2003;4: Suppl 7:S21-30.
|
148
|
Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445.
|
149
|
Sax D, et al. J Card Fail. 2022: 28(10): 1545-59.
|
150
|
Voigt J, et al. Clin Cardiol. 2014;37(5): 312–321.
|
151
|
Heidenreich PA, et al. Circ Heart Fail. 2013;6(3):606-619.
|
152
|
McIlvennan C et al. Circ. 2015;131(20):1796-1803.
|
153
|
See Appendix to Company Investor Presentation filed with the SEC on Form 8-K/A, dated January 9,
2024.
|
154
|
https://idataresearch.com/new-study-shows-approximately-340000-cabg-procedures-per-year-in-the-united-states/.
|
155
|
https://idataresearch.com/over-182000-heart-valve-replacements-per-year-in-the-united-states/.
|
156
|
Kruger A et al. J Cardiovasc Dev Dis. 2023;10(6);263-78.
|
157
|
Bowdish ME, et al. Ann Thorac Surg. 2021; 111(6): 1770-1780.
|
158
|
Grand View Research. Market Research Report. 2015; 978-1-68038-603-5.
|
159
|
Xu J et al. Med. 2015. 94(33):e1360
|
160
|
Xu J, et al. Med. 2015;94(33):e1360. 2017;103:32-40.
|
161
|
Granado RC et al. BMC Nephro. 2016;17:109-18.
|
162
|
Crawford TC, et al. Ann Thorac Surg. 2017;103:32-40.
|
163
|
Iribane A, et al. Ann Thorac Surg. 2014;98:1274-80.
|
164
|
Iribarne A, et al. Ann Thorac Surg. 2014; 98(4): 1274-80.
|
165
|
Beckles DL et al. J Card Surg. 2022; 37: 2951-57.
|
166
|
Engelman D, et al. Ann Thorac Surg. 2023;115:11-5A
|
167
|
See Appendix to Company Investor Presentation filed with the SEC on Form 8-K/A, dated January 9,
2024.
|
168
|
Jayaprasad, N. Heart Views. 2016; 17(3): 92–99.
|
169
|
https://www.cdc.gov/ncbddd/heartdefects/data.html.
|
170
|
Karamlou T, et al. J Thorac Cardiovasc Surg. 2013 Feb;145(2):470-5.
|
171
|
https://www.organdonor.gov/about/donors/child-infant.html.
|
172
|
Sutherland SM, et al. Am J Kidney Dis. 2010;55(2).
|
173
|
Gillespie RS, et al. Ped Nephrol. 2004;19(12): 1394-99.
|
174
|
See Appendix to Company Investor Presentation filed with the SEC on Form 8-K/A, dated January 9,
2024.
|
•
|
Composite win ratio analysis of Cardiovascular (CV) mortality, HF events, and quality of life within 30 days:
|
○
|
CV mortality
|
○
|
HF event
|
○
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
|
•
|
Time to first HF event within 90 days
|
•
|
Time to first HF event or all-cause death within 90 days
|
•
|
HF events within 30 and 90 days
|
•
|
Treatment crossovers
|
175
|
Watson R et al. Am Heart J Plus: Cardiol
Res & Pract 24.2022;1-6.
|
176
|
Watson R, et al. Am Heart J Plus: Cardiol
Res & Pract 24. 2022; 1-6.
|
177
|
Jain A, et al. Heart Fail Rev. 2016;21(5):611-9.
|
178
|
Kazory A, et al. Cardiorenal Med. 2023;13:1-8.
|
179
|
Costanzo MR, et al. Val in Health. 2018: 21(1): s167.
|
180
|
Costanzo MR, et al. Val in Health. 2018: 21(1): s167.
|
181
|
Menon S, et al. Clin J Am Soc Nephrol. 2019 ;14(10):1432-1440.
|
182
|
Menon S, et al. Clin J Am Soc Nephrol. 2019 ;14(10):1432-1440.
|
183
|
Elliott MJ. Ann Thorac Surg. 1993;56:1518-22. fluid overload
|
184
|
Selewski DT, et al. Crit Care Med. 2012; 40(9): 2694-2699.
|
185
|
Riley AA. BMC Nephrology. 2018; 19:268-80.
|
186
|
https://www.ncbi.nlm.nih.gov/pubmed/23833312
|
187
|
Urban S, et al. Adv Clin Exp Med. 2021;30(7):737-746.
|
188
|
Grodin JL, et al. Eur J of Heart Fail. 2018;20(7):1148-1156.
|
189
|
Rao VS, et al. Circ Heart Fail. 2019;12 (6):e005552.
|
190
|
Urban S, et al. Adv Clin Exp Med. 2021;30(7):737-746.
|
191
|
Beckles D. et al. J of Card Surg. Fail. 2022; 37(10): 2951-2957.
|
192
|
Pinney S, et al. Poster from Heart Failure Society of America Meeting; October 2022; Washington, DC.
|
193
|
Hass DC, et al. Amer Heart J Plus.; Cardio
Res & Pract 2022; 24:1-6 (100230)
|
•
|
establishment registration and device listing upon the commencement of manufacturing;
|
•
|
the Quality System Regulation (QSR), which requires manufacturers, including third-party manufacturers, to follow the FDA design
control regulations;
|
•
|
labeling regulations, which prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on
labeling and promotional activities;
|
•
|
medical device reporting regulations, which require that manufacturers report to the FDA if a device may have caused or
contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if malfunctions were to recur;
|
•
|
corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections; and
|
•
|
product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDC Act
caused by the device that may present a risk to health.
|
•
|
warning letters or untitled letters;
|
•
|
fines, injunctions and civil penalties;
|
•
|
product recall or seizure;
|
•
|
unanticipated expenditures;
|
•
|
delays in clearing or refusal to clear products;
|
•
|
withdrawal or suspension of FDA clearance;
|
•
|
orders for physician notification or device repair, replacement or refund;
|
•
|
operating restrictions, partial suspension or total shutdown of production or clinical trials; or
|
•
|
criminal prosecution.
|